The following data is part of a premarket notification filed by Myoscience, Inc with the FDA for Iovera System.
| Device ID | K161835 |
| 510k Number | K161835 |
| Device Name: | Iovera System |
| Classification | Device, Surgical, Cryogenic |
| Applicant | Myoscience, Inc 46400 Fremont Blvd Fremont, CA 94538 |
| Contact | Tracey Henry |
| Correspondent | Tracey Henry Myoscience, Inc 46400 Fremont Blvd Fremont, CA 94538 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2017-03-24 |
| Summary: | summary |