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510(k) K163107

Lifestyles Zero Lubricated Latex Male Condom by Ansell Healthcare Products, LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2017
Date Received
November 7, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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