REPHRESH VAGINAL GEL
Lubricant, Personal
COLUMBIA LABORATORIES, INC.
The following data is part of a premarket notification filed by Columbia Laboratories, Inc. with the FDA for Rephresh Vaginal Gel.
Pre-market Notification Details
| Device ID | K021737 |
| 510k Number | K021737 |
| Device Name: | REPHRESH VAGINAL GEL |
| Classification | Lubricant, Personal |
| Applicant | COLUMBIA LABORATORIES, INC. 100 NORTH VILLAGE AVE. SUITE 32 Rockville Centre, NY 11570 |
| Contact | Susan A Witham |
| Correspondent | Susan A Witham COLUMBIA LABORATORIES, INC. 100 NORTH VILLAGE AVE. SUITE 32 Rockville Centre, NY 11570 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-08-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600987628 | K021737 | 000 |
| 00022600019657 | K021737 | 000 |
| 00022600001133 | K021737 | 000 |
| 00022600001119 | K021737 | 000 |
Trademark Results [REPHRESH VAGINAL GEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REPHRESH VAGINAL GEL 76318002 2757071 Live/Registered |
CHURCH & DWIGHT CO., INC. 2001-09-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.