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 |
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 |
|
|