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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 K915285
Device Name SKYTRON INFINITY SERIES SURGICAL LIGHTS
Original Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36th st., s.e.
grand rapids,  MI  49512
Original Contact larry purcey
Regulation Number878.4580
Classification Product Code
FSY  
Date Received11/25/1991
Decision Date 02/20/1992
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
Recalls CDRH Recalls
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