510(k) K002596 ยท MLY Vapocoolant Device
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
| Applicant | Gebauer Co., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 15, 2001 |
| Received | Aug 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2008 | Gebauer Company Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator.
Gebauer's Fluro-Ethyl is a vapocoolan Terminated |
MLY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.