The following data is part of a premarket notification filed by Vapocoolshot, Inc. with the FDA for Vapocoolshot Mist.
| Device ID | K193349 |
| 510k Number | K193349 |
| Device Name: | Vapocoolshot Mist |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | Vapocoolshot, Inc. 1155 Main Street, Suite 105 Jupiter, FL 33458 |
| Contact | Jacob Leibovici |
| Correspondent | Neil Ross N2Pharma, LLC 1071 Nandina Dr Weston, FL 33327 |
| 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 | 2019-12-03 |
| Decision Date | 2020-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860006961586 | K193349 | 000 |
| 00860006961589 | K193349 | 000 |
| 30860006961504 | K193349 | 000 |
| 10860006961500 | K193349 | 000 |
| 00860006961558 | K193349 | 000 |
| 00860006961541 | K193349 | 000 |
| 20860006961507 | K193349 | 000 |
| 00860006961503 | K193349 | 000 |