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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 K021585
Device Name STELLAR SERIES SURGICAL LIGHTS WITH HERMES
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS,  MI  49512
Applicant Contact KARI OGREEN
Correspondent
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS,  MI  49512
Correspondent Contact KARI OGREEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received05/14/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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