The following data is part of a premarket notification filed by Pacira Pharmaceuticals Inc. with the FDA for Iovera System.
| Device ID | K211334 |
| 510k Number | K211334 |
| Device Name: | Iovera System |
| Classification | Device, Surgical, Cryogenic |
| Applicant | Pacira Pharmaceuticals Inc. 46400 Fremont Blvd Fremont, CA 94538 |
| Contact | Kent Jones |
| Correspondent | Kent Jones Pacira Pharmaceuticals Inc. 46400 Fremont Blvd Fremont, CA 94538 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816287020248 | K211334 | 000 |
| 00816287020224 | K211334 | 000 |
| 00816287020200 | K211334 | 000 |