510(k) K032671 ยท MLY Vapocoolant Device
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
| Applicant | Gebauer Co., Cleveland OH, US |
| Decision | Substantially Equivalent, Mar 17, 2004 |
| Received | Aug 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032671
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02 Terminated |
MLY | None listed |
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0 Terminated |
MLY | None listed |
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01) Terminated |
MLY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.