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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.Sw 2007
Australia,  AU
Applicant Contact KALNIN
Correspondent
Ashai Co. , Ltd.
620 Harris St.
Ultimo, N.Sw 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
Predetermined Change
Control Plan Authorized		 No
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