FDA 510(k) Applications for Medical Device:
Colposcope (And Colpomicroscope)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001314 | ALL-PRO IMAGING CORP. |
70 CANTIAGUE ROCK RD. | HICKSVILLE | NY | 11801 |
| K182764 | Biop Medical Ltd. |
10 O'haliav Street | Ramat-Gan | 5252263 | |
| K992544 | CIRCON CORP. |
6500 HOLLISTER AVE. | SANTA BARBARA | CA | 93117-3019 |
| K140754 | COOPER SURGICAL, INC. |
80 SHELTON TECHNOLOGY CENTER | SHELTON | CT | 06484 |
| K972630 | COOPERSURGICAL, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K021854 | D.F. VASCONCELLOS S.A. |
1990 NE 163 RD ST. | NORTH MIAMI | FL | 33162 |
| K100595 | Ecleris USA |
12225 WORLD TRADE DRIVE | SAN DIEGO | CA | 92128 |
| K151878 | EDAN INSTRUMENTS, INC. |
3/F- B, Nanshan Medical Equipments Park | Shenzhen | 518067 | |
| K092433 | FORTH PHOTONICS HELLAS SA |
690 CANTON ST, SUITE 302 | WESTWOOD | MA | 02090 |
| K021153 | GOLDWAY US, INC. |
12 SOUTH FIRST STREET, | SAN JOSE | CA | 95113 |
| K061306 | GYNEX CORP. |
2789 152ND AVE., NE | REDMOND | WA | 98052 |
| K132423 | GYNIUS AB |
DOBELNSGATAN 23 | STOCKHOLM | 11140 | |
| K181034 | Hadleigh Health Technologies, LLC |
30 Castro Ave. | San Rafael | CA | 94901 |
| K190187 | Illumigyn Ltd. |
Communication Center | Neve Ilan | 9085000 | |
| K031639 | INTERMED GROUP, INC. |
3550 23RD AVE. SOUTH, SUITE #1 | LAKE WORTH | FL | 33461 |
| K963593 | INVENTIVE MEDICAL TECHNOLOGY |
4361 BAILDON RD. | TRAPPE | MD | 21673-1807 |
| K000707 | LEICA MICROSCOPY SYSTEMS LTD. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K160380 | Lutech Industries, Inc. |
105 Remington Blvd., Suite C | Ronkonkoma | NY | 11779 |
| K170446 | Lutech Industries, Inc. |
105 Remington Blvd | Ronkonkoma | NY | 11779 |
| K143119 | Lutech Industries, Inc. |
105 Remington Blvd., Suite C | Ronkonkoma | NY | 11779 |
| K122973 | MEDGYN PRODUCTS, INC. |
12 SOUTH FIRST STREE | SAN JOSE | CA | 95113 |
| K161871 | MobileODT Ltd. |
41 Gershon Shatz St., 2nd Floor | Tel Aviv | 6701779 | |
| K981958 | NETOPTIX CORP. |
49 PLAIN ST. | NORTH ATTLEBORO, | MA | 02760 |
| K233043 | Periwinkle Technologies Pvt. Ltd |
B1, Samrat Ashok CHS, S. No. 88/2, Veerbhadra Nagar, Baner, | Pune | 411045 | |
| K101141 | SEILER PRECISION MICROSCOPES |
3433 TREE CT INDUSTRIAL BLVD | ST. LOUIS | MO | 63122 |
| K122311 | SHENZHEN GOLDCARE MEDITECH CO., LTD. |
2600 MISSION STREET | SAN MARINO | CA | 91108 |
| K031436 | SOMETECH CORPORATION |
6669 PEACHTREE INDUSTRIAL BLVD | NORCROSS | GA | 30092 |
| K070845 | SOUNMED, INC. |
6800 N.W. 77TH COURT | MIAMI | FL | 33166 |
| K072691 | STI MEDICAL SYSTEMS |
733 BISHOP STREET | HONOLULU | HI | 96813 |
| K090324 | STI MEDICAL SYSTEMS |
733 BISHOP STREET | HONOLULU | HI | 96813 |
| K110147 | STI MEDICAL SYSTEMS, LLC |
4275 EXECUTIVE SQUARE, | LA JOLLA | CA | 92037 |
| K073053 | UNITED PRODUCTS & INSTRUMENTS, INC. |
377 ROUTE 17 S | HASBROUCK | NJ | 07604 |
| K033870 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K955635 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K160341 | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD |
KERNEL MANSION, ECONOMIC DEVELOPMENT DISTRICT | XUZHOU | 221004 |
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