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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 K070442
Device Name POWERLED SURGICAL LIGHT SYSTEM
Applicant
MAQUET S.A.
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623
Applicant Contact KEVIN M TOMPKINS
Correspondent
MAQUET S.A.
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623
Correspondent Contact KEVIN M TOMPKINS
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/15/2007
Decision Date 03/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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