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 cannula, manipulator/injector, uterine
510(k) Number K142716
Device Name VCARE
Applicant
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Applicant Contact ANNA D'LIMA
Correspondent
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Correspondent Contact ANNA D'LIMA
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/23/2014
Decision Date 02/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-