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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 K093556
Device Name VCARE DX
Applicant
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Applicant Contact SARAH RIZK
Correspondent
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Correspondent Contact SARAH RIZK
Regulation Number884.4530
Classification Product Code
LKF  
Date Received11/17/2009
Decision Date 03/12/2010
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
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