Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
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
-
-