PREPEX SYSTEM


Device Classification Name

clamp, circumcision

510(k) Number K103695
Device Name PREPEX SYSTEM
Applicant
CIRC MEDTECH
1914 j.n. pease place
charlotte, 
NC 
28262

Applicant Contact shoshana friedman
Correspondent
CIRC MEDTECH
1914 j.n. pease place
charlotte, 
NC 
28262

Correspodent Contact shoshana friedman
Regulation Number 884.4530
Classification Product Code
HFX  
Date Received 12/17/2010
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 NCT01150370NCT01284088
Reviewed by Third Party No

Combination Product

No