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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K160399
Device Name Skyn Original Polyisoprene Lubricated Male Condom
Applicant
Ansell Healthcare Products, LLC
111 Wood Avenue South, Suite 210
Iselin,  NJ  08830
Applicant Contact Robert Mahler
Correspondent
Ansell Healthcare Products, LLC
111 Wood Avenue South, Suite 210
Iselin,  NJ  08830
Correspondent Contact Robert Mahler
Regulation Number884.5300
Classification Product Code
MOL  
Date Received02/12/2016
Decision Date 07/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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