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510(k) K171172

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2017
Date Received
April 21, 2017
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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