The following data is part of a premarket notification filed by Myoscience, Inc with the FDA for Iovera System.
| Device ID | K173763 |
| 510k Number | K173763 |
| Device Name: | Iovera System |
| Classification | Device, Surgical, Cryogenic |
| Applicant | Myoscience, Inc 46400 Fremont Blvd Fremont, CA 94538 |
| Contact | Kent Jones |
| Correspondent | Kent Jones 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 | 2017-12-11 |
| Decision Date | 2018-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816287020071 | K173763 | 000 |
| 00816287020170 | K173763 | 000 |
| 00816287020132 | K173763 | 000 |
| 00816287020101 | K173763 | 000 |