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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, Fiberoptic
510(k) Number K093386
Device Name CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
Applicant
BFW, INC
2307 RIVER ROAD
SUITE 103
LOUISVILLE,  KY  40206
Applicant Contact LYNN COOPER
Correspondent
BFW, INC
2307 RIVER ROAD
SUITE 103
LOUISVILLE,  KY  40206
Correspondent Contact LYNN COOPER
Regulation Number878.4580
Classification Product Code
FST  
Date Received10/30/2009
Decision Date 01/28/2010
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
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