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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K021737
FOIA Releasable 510(k) K021737
Device Name REPHRESH VAGINAL GEL
Applicant
Columbia Laboratories, Inc.
100 N. Village Ave.
Suite 32
Rockville Centre,  NY  11570
Applicant Contact SUSAN A WITHAM
Correspondent
Columbia Laboratories, Inc.
100 N. Village Ave.
Suite 32
Rockville Centre,  NY  11570
Correspondent Contact SUSAN A WITHAM
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/28/2002
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
Predetermined Change
Control Plan Authorized		 No
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