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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K001597
Device Name CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501
Applicant Contact IRA D DUESLER, JR.
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501
Correspondent Contact IRA D DUESLER, JR.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/23/2000
Decision Date 06/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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