The following data is part of a premarket notification filed by Bfw, Inc with the FDA for Chromalume Turbo Light Source With Xtremebeam Fiber Optic Headlampfst Model Fst.
| Device ID | K093386 |
| 510k Number | K093386 |
| Device Name: | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | BFW, INC 2307 RIVER ROAD SUITE 103 Louisville, KY 40206 |
| Contact | Lynn Cooper |
| Correspondent | Lynn Cooper BFW, INC 2307 RIVER ROAD SUITE 103 Louisville, KY 40206 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-01-28 |
| Summary: | summary |