The following data is part of a premarket notification filed by Pacira Biosciences, Inc. with the FDA for Iovera System.
| Device ID | K220656 |
| 510k Number | K220656 |
| Device Name: | Iovera System |
| Classification | Device, Surgical, Cryogenic |
| Applicant | Pacira Biosciences, Inc. 10450 Science Center Drive San Diego, CA 92121 |
| Contact | Danny Rivera |
| Correspondent | Danny Rivera Pacira Biosciences, Inc. 10450 Science Center Drive San Diego, CA 92121 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816287020279 | K220656 | 000 |