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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, Ceiling Mounted
510(k) Number K914076
Device Name MDT/CASTLE 2000 SURGICAL LIGHTS
Applicant
MDT CORP., INC.
1777 EAST HENRIETTA RD.(14623)
P.O. BOX 23077
ROCHESTER,  NY  14692
Applicant Contact MARK N SMITH
Correspondent
MDT CORP., INC.
1777 EAST HENRIETTA RD.(14623)
P.O. BOX 23077
ROCHESTER,  NY  14692
Correspondent Contact MARK N SMITH
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/11/1991
Decision Date 11/13/1991
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
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