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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 K900211
Device Name SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Applicant Contact LARRY J PURCEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Correspondent Contact LARRY J PURCEY
Regulation Number878.4580
Classification Product Code
FSY  
Date Received01/17/1990
Decision Date 03/19/1990
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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