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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cannula, surgical, general & plastic surgery
510(k) Number K954599
Device Name CONMED TROGARD ELECTRONIC TROCAR SYSTEM
Applicant
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Applicant Contact IRA D DUESLER
Correspondent
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Correspondent Contact IRA D DUESLER
Regulation Number878.4800
Classification Product Code
GEA  
Subsequent Product Code
GEI  
Date Received10/03/1995
Decision Date 11/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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