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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 K961175
Device Name TROGARD TROCAR DIALATING TROCAR SYSTEM
Applicant
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401
Applicant Contact IRA D DUESLER, JR.
Correspondent
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401
Correspondent Contact IRA D DUESLER, JR.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/25/1996
Decision Date 04/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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