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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 K932983
Device Name COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
Applicant
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Applicant Contact HELEN MARIESKIND
Correspondent
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Correspondent Contact HELEN MARIESKIND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/18/1993
Decision Date 07/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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