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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 K971132
Device Name ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
Applicant
G. PREMJEE (USA), INC.
55 NORTHER BLVD. SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
G. PREMJEE (USA), INC.
55 NORTHER BLVD. SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/27/1997
Decision Date 09/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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