The following data is part of a premarket notification filed by Cryoscience North America, Inc. with the FDA for Cryo Arctic, Cryo Penguin.
| Device ID | K203661 |
| 510k Number | K203661 |
| Device Name: | CRYO Arctic, CRYO Penguin |
| Classification | Vapocoolant Device |
| Applicant | CryoScience North America, Inc. 401 Louisuana St, 8th Floor Houston, TX 77002 -1629 |
| Contact | Greg Nehrlich |
| Correspondent | Robert Seiple QPM Consulting, LLC 3817 Seville Rd Denton, TX 76205 |
| 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 | 2020-12-15 |
| Decision Date | 2022-05-25 |