510(k) K031036 ยท MLY Vapocoolant Device
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
| Applicant | Gebauer Co., Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 10, 2003 |
| Received | Apr 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | Gebauer Company Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary reli Terminated |
MLY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.