510(k) K061690 ยท FST Light, Surgical, Fiberoptic
SURGICAL HEADLIGHT
| Applicant | Gulf Medical Fiberoptics, Oldsmar FL, US |
| Decision | Substantially Equivalent, Sep 15, 2006 |
| Received | Jun 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2012 | Gulf Medical Fiberoptics, Inc. Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical He Terminated |
FST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.