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FDA 510(k) Application Details - K093386
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
510(K) Number
K093386
Device Name
Light, Surgical, Fiberoptic
Applicant
BFW, INC
2307 RIVER ROAD
SUITE 103
LOUISVILLE, KY 40206 US
Other 510(k) Applications for this Company
Contact
LYNN COOPER
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FST
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2009
Decision Date
01/28/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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