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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K901108
Device Name FIBERLUME
Applicant
Burton
7922 Haskell Ave.
Van Nuys,  CA  91406
Applicant Contact GRETEL ANDERSON
Correspondent
Burton
7922 Haskell Ave.
Van Nuys,  CA  91406
Correspondent Contact GRETEL ANDERSON
Regulation Number878.4580
Classification Product Code
HBI  
Date Received03/09/1990
Decision Date 03/28/1990
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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