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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, accessories
510(k) Number K954940
Device Name MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
Applicant
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Applicant Contact CHARLES O HANCOCK
Correspondent
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Correspondent Contact CHARLES O HANCOCK
Regulation Number878.4580
Classification Product Code
FTA  
Date Received10/30/1995
Decision Date 01/17/1996
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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