REPHRESH VAGINAL GEL


Device Classification Name

lubricant, personal

510(k) Number K021737
Device Name REPHRESH VAGINAL GEL
Original Applicant
COLUMBIA LABORATORIES, INC.
100 north village ave.
suite 32
rockville centre, 
NY 
11570

Original Contact susan a witham
Regulation Number 884.5300
Classification Product Code
NUC  
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