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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 K946220
Device Name CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
Applicant
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Applicant Contact IRA D DUESLER, JR.
Correspondent
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Correspondent Contact IRA D DUESLER, JR.
Regulation Number884.4530
Classification Product Code
LKF  
Date Received12/21/1994
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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