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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 K000639
Device Name VISIONARY 2000
Applicant
Burton Medical Products Corp.
21100 Lassen St.
Chatsworth,  CA  91311
Applicant Contact DORIAN SWARTZ
Correspondent
Burton Medical Products Corp.
21100 Lassen St.
Chatsworth,  CA  91311
Correspondent Contact DORIAN SWARTZ
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/25/2000
Decision Date 05/25/2000
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
Predetermined Change
Control Plan Authorized		 No
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