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510(k) K142163

MALE CIRCUMCISION KITS:RAPIDECLAMP by Medicfit Technology Sdn Bhd — Product Code HFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2015
Date Received
August 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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