Device Classification Name |
lubricant, personal
|
510(k) Number |
K021737 |
FOIA Releasable 510(k) |
K021737
|
Device Name |
REPHRESH VAGINAL GEL |
Applicant |
COLUMBIA LABORATORIES, INC. |
100 NORTH VILLAGE AVE. |
SUITE 32 |
ROCKVILLE CENTRE,
NY
11570
|
|
Applicant Contact |
SUSAN A WITHAM |
Correspondent |
COLUMBIA LABORATORIES, INC. |
100 NORTH VILLAGE AVE. |
SUITE 32 |
ROCKVILLE CENTRE,
NY
11570
|
|
Correspondent Contact |
SUSAN A WITHAM |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/28/2002 |
Decision Date | 08/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|