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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 K913813
Device Name JIFFI CONDOM (RUBBER) CONTRACEPTIVE
Applicant
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Applicant Contact HELEN I MARIESKIND
Correspondent
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Correspondent Contact HELEN I MARIESKIND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/26/1991
Decision Date 06/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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