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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 K932985
Device Name AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
Applicant
SIME HEALTH, LTD.
1200 SIXTH AVE. SOUTH
SEATTLE,  WA  98134
Applicant Contact HELEN MARIESKIND
Correspondent
SIME HEALTH, LTD.
1200 SIXTH AVE. SOUTH
SEATTLE,  WA  98134
Correspondent Contact HELEN MARIESKIND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/18/1993
Decision Date 06/16/1995
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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