The following data is part of a premarket notification filed by Gebauer Company with the FDA for Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint Spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray.
| Device ID | K190161 |
| 510k Number | K190161 |
| Device Name: | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint Spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | Gebauer Company 4444 East 153rd Street Cleveland, OH 44128 |
| Contact | Brittney Cooper |
| Correspondent | Brittney Cooper Gebauer Company 4444 East 153rd Street Cleveland, OH 44128 |
| 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 | 2019-01-30 |
| Decision Date | 2019-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10303860001031 | K190161 | 000 |
| 20303860001137 | K190161 | 000 |
| 20303860001113 | K190161 | 000 |
| 00303860001041 | K190161 | 000 |
| 00303860001027 | K190161 | 000 |