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510(k) K160399

Skyn Original Polyisoprene Lubricated Male Condom by Ansell Healthcare Products, LLC — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2016
Date Received
February 12, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom, Synthetic
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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