FDA 510(k) Applications for Medical Device:
Keratome, Ac-Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983317 | BARRON PRECISION INSTRUMENTS, L.L.C. |
PO BOX 973, 8170 EMBURY RD. | GRAND BLANC | MI | 48439-0973 |
| K021640 | BAUSCH & LOMB, INC. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K010260 | BAUSCH & LOMB, INC. |
9342 JERONIMO RD. | IRVINE | CA | 92618 |
| K062465 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K040204 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K042083 | BIOVISION AG |
27 MAUCHLY, UNIT 206 | IRVINE | CA | 92618 |
| K014000 | BIOVISION AG |
27 MAUCHLY, UNIT 206 | IRVINE | CA | 92618 |
| K993225 | BLADE WORKS, INC. |
107 SOUTH COVINGTON ST. | HILLSBORO | TX | 76445 |
| K020079 | BLADE WORKS, INC. |
1816 TOWHEE ST. | SAN MARCOS | CA | 92069 |
| K173371 | Carl Zeiss Meditec, Inc. |
5160 Hacienda Drive | Dublin | CA | 94568 |
| K972808 | CHIRON VISION CORP. |
9342 JERONIMO RD. | IRVINE | CA | 92618-1903 |
| K031735 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K032978 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K041206 | GEBAUER MEDIZINTECHNIK GMBH |
54 FOREST STREET | LEXINGTON | MA | 02421 |
| K072102 | GEBAUER MEDIZINTECHNIK GMBH |
54 FOREST STREET | LEXINGTON | MA | 02421 |
| K981155 | HAWKEN INDUSTRIES |
26650 RENAISSANCE PKWY., STE.3 | CLEVELAND | OH | 44128 |
| K052891 | HAWKEN INDUSTRIES |
377 ROUTE 17 S | HASBROUCK HEIGHTS | NJ | 07604 |
| K972727 | HOWARD INSTRUMENTS, INC. |
4749 APPLETREE LN. | TUSCALOOSA | AL | 35405-5747 |
| K974598 | HOWARD INSTRUMENTS, INC. |
4749 APPLETREE LN. | TUSCALOOSA | AL | 35405-5747 |
| K980985 | HOWARD INSTRUMENTS, INC. |
4749 APPLETREE LN. | TUSCALOOSA | AL | 35405-5747 |
| K973294 | INNOVATIVE OPTICS, INC. |
4307 CEDARWOOD DR. | LILBURN | GA | 30247 |
| K984540 | KERAVISION, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K974004 | LASERSIGHT TECHNOLOGIES, INC. |
12249 SCIENCE DRIVE, SUITE 160 | ORLANDO | FL | 32826 |
| K001144 | LASERSIGHT TECHNOLOGIES, INC. |
3300 UNIVERSITY BLVD. | WINTER PARK | FL | 32792 |
| K990227 | LASERSIGHT TECHNOLOGIES, INC. |
3300 UNIVERSITY BLVD. | WINTER PARK | FL | 32792 |
| K022716 | MED-LOGICS, INC. |
26061 MERIT CIRCLE, SUITE #102 | LAGUNA HILLS | CA | 92653 |
| K022982 | MED-LOGICS, INC. |
26061 MERIT CIRCLE, SUITE #102 | LAGUNA HILLS | CA | 92653 |
| K033293 | MED-LOGICS, INC. |
26061 MERIT CIRCLE, SUITE #102 | LAGUNA HILLS | CA | 92653 |
| K002515 | MED-LOGICS, INC. |
30001 GOLDEN LANTERN #334 | LAGUNA NIGUEL | CA | 92677 |
| K010872 | MED-LOGICS, INC. |
27881 LA PAZ #G316 | LAGUNA NIGUEL, | CA | 92677 |
| K981071 | MED-LOGICS, INC. |
30251 GOLDEN LANTERN | LAGUNA NIGUEL | CA | 92677 |
| K962661 | MED-LOGICS, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780 |
| K993122 | MEDICAL STERILE PRODUCTS, INC. |
RD. 413, KM. 0.2 | RINCON | PR | 00677 |
| K981554 | MICRA INSTRUMENTS LTD. |
52 BILTON WAY | LUTON | LU1 1UU | |
| K033457 | MICRO SPECIALTIES, INC. |
264 QUARRY ROAD | MILFORD | CT | 06460 |
| K980510 | MICROSPECIALTIES, INC. |
16 HIGGINS DR. | MILFORD | CT | 06460 |
| K020482 | MICROSPECIALTIES, INC. |
264 QUARRY RD. | MILFORD | CT | 06460 |
| K980508 | MICROSPECIALTIES, INC. |
16 HIGGINS DR. | MILFORD | CT | 06460 |
| K020122 | MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. | POMONA | CA | 91767 |
| K011833 | MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. | POMONA | CA | 91767 |
| K041110 | MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. | POMONA | CA | 91767 |
| K003143 | MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. | POMONA | CA | 91767 |
| K001806 | MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. | POMONA | CA | 91767 |
| K043183 | MORIA S.A. |
15 RUE GEORGES BESSE | ANTONY | 92160 | |
| K032836 | MORIA S.A. |
15 RUE GEORGES BESSE | ANTONY | 92160 | |
| K172994 | Moria SA |
15 Rue Georges Besse | Antony | ||
| K981742 | MORIA, INC. |
15 RUE GEORGES BESSE | ANTONY | 92160 | |
| K990900 | NIDEK, INC. |
47651 WESTINGHOUSE DR. | FREMONT | CA | 94539 |
| K042810 | NORWOOD ABBEY , LTD. |
63 WELLS RD. | CHELSEA HGTS., VICTORIA | 3196 | |
| K051486 | NORWOOD ABBEY , LTD. |
63 WELLS RD. | CHELSEA HGTS., VICTORIA | 3196 | |
| K001464 | OASIS |
514 SOUTH VERMONT AVE. | GLENDORA | CA | 91741 |
| K003820 | OASIS MEDICAL, INC. |
514 S. VERMONT AVE. | GLENDORA | CA | 91741 |
| K030401 | OASIS MEDICAL, INC. |
512 S. VERMONT AVE. | GLENDORA | CA | 91741-6205 |
| K001176 | OASIS MEDICAL, INC. |
514 S. VERMONT AVE. | GLENDORA | CA | 91741 |
| K032297 | OASIS MEDICAL, INC. |
512 S. VERMONT AVE. | GLENDORA | CA | 91741-6205 |
| K022205 | OASIS MEDICAL, INC. |
514 SOUTH VERMONT AVE. | GLENDORA | CA | 91741 |
| K970377 | PLANCON INSTRUMENTS |
15 RUE GEORGES BESSE | ANTHONY | 92160 | |
| K980924 | PLANCON INSTRUMENTS |
15 RUE GEORGES BESSE | ANTONY | 92160 | |
| K960395 | PLANCON INSTRUMENTS |
15 RUE GEORGES BESSE | ANTHONY | 92160 | |
| K032910 | SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG |
23832 VIA MONTE | COTO DE CAZA | CA | 92679 |
| K082043 | SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG |
MAINPARKSTRASSE 6-10 | KLEINOSTHEIM | 63801 | |
| K043150 | SIS LTD. SURGICAL INSTRUMENT SYSTEMS |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K980675 | SUMMIT TECHNOLOGY, INC. |
21 HICKORY DR. | WALTHAM | MA | 02154 |
| K993190 | SURGICAL INSTRUMENT SYSTEMS (SIS), LTD |
18732 SAGINAW | IRVINE | CA | 92612 |
| K002849 | SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. | READING | PA | 19606 |
| K013337 | SURGIN INC |
14762 BENTLEY CIRCLE | TUSTIN | CA | 92680 |
| K994015 | SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE | TUSTIN | CA | 92680 |
| K011195 | SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE | TUSTIN | CA | 92680 |
| K033182 | SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE | TUSTIN | CA | 92680 |
| K033236 | SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE | TUSTIN | CA | 92680 |
| K992978 | SURGISTAR, INC. |
6068 CORTE DEL CEDRO | CARLSBAD | CA | 92009 |
| K030891 | SURGISTAR, INC. |
6068 CORTE DEL CEDRO | CARLSBAD | CA | 92009 |
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