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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K103695
Device Name PREPEX SYSTEM
Applicant
Circ Medtech
1914 J.N. Pease Place
Chalotte,  NC  28262
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Circ Medtech
1914 J.N. Pease Place
Chalotte,  NC  28262
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number884.4530
Classification Product Code
HFX  
Date Received12/17/2010
Decision Date 01/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01150370
NCT01284088
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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