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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 K002463
Device Name STELLAR
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588
Applicant Contact KARI OGREEN
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588
Correspondent Contact KARI OGREEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received08/10/2000
Decision Date 11/08/2000
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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