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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 K933153
Device Name PENTHOUSE CONDOMS
Applicant
KURON HEALTH PRODUCTS CORP.
4101 BALFOUR AVE.
OAKLAND,  CA  94610
Applicant Contact JEFFREY KIM
Correspondent
KURON HEALTH PRODUCTS CORP.
4101 BALFOUR AVE.
OAKLAND,  CA  94610
Correspondent Contact JEFFREY KIM
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received06/29/1993
Decision Date 07/28/1994
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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