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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K071907
Device Name VCARE RETRACTOR/ELEVATOR
Applicant
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Applicant Contact BRIAN KILLORAN
Correspondent
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Correspondent Contact BRIAN KILLORAN
Regulation Number884.4530
Classification Product Code
LKF  
Date Received07/10/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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