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 K061539
Device Name GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
Applicant
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Applicant Contact WM DEAN WALLACE
Correspondent
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Correspondent Contact WM DEAN WALLACE
Regulation Number884.4530
Classification Product Code
HFX  
Date Received06/05/2006
Decision Date 09/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-