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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K910678
Device Name TRO-GARD
Applicant
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Applicant Contact WILLIAM W ABRAHAM
Correspondent
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number880.5240
Classification Product Code
KGX  
Date Received02/15/1991
Decision Date 05/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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