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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 K955446
Device Name CONMED VCARE RETRACTOR/ELEVATOR
Applicant
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401 -1408
Applicant Contact IRA D DUESLER, JR.
Correspondent
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401 -1408
Correspondent Contact IRA D DUESLER, JR.
Regulation Number884.4530
Classification Product Code
LKF  
Date Received11/29/1995
Decision Date 06/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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