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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 K852620
Device Name SAFE.N.SURE
Applicant
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Applicant Contact KALNIN
Correspondent
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Correspondent Contact KALNIN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/20/1985
Decision Date 10/31/1985
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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