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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 K884454
Device Name SAFECON CONDOMS - RIBBED
Applicant
QUALITY SYNTHETICS INTL, INC.
12821 WESTERN AVE., SUITE J
GARDEN GROVE,  CA  92641
Applicant Contact CAROLYN DAVIS
Correspondent
QUALITY SYNTHETICS INTL, INC.
12821 WESTERN AVE., SUITE J
GARDEN GROVE,  CA  92641
Correspondent Contact CAROLYN DAVIS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/24/1988
Decision Date 04/25/1989
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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