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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, Floor Standing
510(k) Number K910942
Device Name AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
Applicant
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Applicant Contact MARK N SMITH
Correspondent
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Correspondent Contact MARK N SMITH
Regulation Number878.4580
Classification Product Code
FSS  
Date Received03/06/1991
Decision Date 06/11/1991
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
Predetermined Change
Control Plan Authorized		 No
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