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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 K071698
Device Name AURORA LED SERIES SURGICAL LIGHTS
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS,  MI  49512
Applicant Contact LARRY PEREZ
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received06/21/2007
Decision Date 07/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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