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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 K934799
Device Name CONMED TROGARD
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501
Applicant Contact IRA D DUESLER
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501
Correspondent Contact IRA D DUESLER
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
KNF  
Date Received10/07/1993
Decision Date 12/21/1994
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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