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510(k) K132597

BLACK COLOURED CONDOM by Karex Industries Sdn. Bhd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2013
Date Received
August 19, 2013
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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