The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Fluori Methane Ss- A Vapocoolant/skin Ref. Device.
| Device ID | K930915 |
| 510k Number | K930915 |
| Device Name: | FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | GEBAUER CO. 1920 N. STREET, N.W. Washington, DC 20036 |
| Contact | Norman Philion |
| Correspondent | Norman Philion GEBAUER CO. 1920 N. STREET, N.W. Washington, DC 20036 |
| Product Code | MLY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1994-09-29 |