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510(k) K113061

LARGE/EXTRA LAGRE CONDOM by Karex Industries Sdn. Bhd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2011
Date Received
October 14, 2011
Clearance Type
Special
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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