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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 K101537
Device Name AIM 200, MAJOR SURGICAL LIGHT
Applicant
Burton Medical Products Corp.
21100 Lassen St.
Chatsworth,  CA  91311
Applicant Contact SCOT KINGHORN
Correspondent
Burton Medical Products Corp.
21100 Lassen St.
Chatsworth,  CA  91311
Correspondent Contact SCOT KINGHORN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received06/03/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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