FDA 510(k) Application Details - K103695

Device Classification Name Clamp, Circumcision

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510(K) Number K103695
Device Name Clamp, Circumcision
Applicant CIRC MEDTECH
1914 J.N. PEASE PLACE
CHARLOTTE, NC 28262 US
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Contact SHOSHANA FRIEDMAN
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Regulation Number 884.4530

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Classification Product Code HFX
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Date Received 12/17/2010
Decision Date 01/10/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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