The following data is part of a premarket notification filed by Cryonic Medical North America with the FDA for Cryotron 2 Cryotherapy Device.
| Device ID | K030281 |
| 510k Number | K030281 |
| Device Name: | CRYOTRON 2 CRYOTHERAPY DEVICE |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | CRYONIC MEDICAL NORTH AMERICA 1350 DANIELSON RD. Montecito, CA 93108 |
| Contact | Sandra Williamson |
| Correspondent | Sandra Williamson CRYONIC MEDICAL NORTH AMERICA 1350 DANIELSON RD. Montecito, CA 93108 |
| 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 | 2003-01-27 |
| Decision Date | 2003-08-20 |
| Summary: | summary |