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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K972836
Device Name ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR 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 Number884.5310
Classification Product Code
LTZ  
Date Received07/31/1997
Decision Date 10/22/1997
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
Predetermined Change
Control Plan Authorized		 No
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