The following data is part of a premarket notification filed by Vapocoolshot, Inc. with the FDA for Syringe Holder Accessory.
| Device ID | K201248 |
| 510k Number | K201248 |
| Device Name: | Syringe Holder Accessory |
| 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 | 2020-05-11 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006961534 | K201248 | 000 |
| 00860006961510 | K201248 | 000 |