CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST— 510(k) K093386

Name: FDA 510(k) clearance K093386
Creator: U.S. Food and Drug Administration
Published: 2010-01-28

Substantially Equivalent

Bfw, Inc.

FDA 510(k) clearance K093386 for CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST, Substantially Equivalent on 2010-01-28. Applicant: Bfw, Inc.. Device class: 2.

Clearance details

Applicant: Bfw, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2009-10-30
Decision date: 2010-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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