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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K871300
Device Name VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA
Applicant
PROFESSIONAL PHARMACY WEST, INC.
567 KING ST.
CHARLESTON,  SC  29403
Applicant Contact BARRY BLOOM
Correspondent
PROFESSIONAL PHARMACY WEST, INC.
567 KING ST.
CHARLESTON,  SC  29403
Correspondent Contact BARRY BLOOM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/01/1987
Decision Date 06/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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