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 |