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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K946235
Device Name CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
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 Number884.1720
Classification Product Code
HET  
Date Received12/22/1994
Decision Date 02/13/1995
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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