The following data is part of a premarket notification filed by Spirox, Inc. with the FDA for Inex Absorbable Nasal Implant.
| Device ID | K152958 |
| 510k Number | K152958 |
| Device Name: | INEX Absorbable Nasal Implant |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | SPIROX, INC. 3475-O EDISON WAY Menlo Park, CA 94025 |
| Contact | Mike Rosenthal |
| Correspondent | Mike Rosenthal SPIROX, INC. 3475-O EDISON WAY Menlo Park, CA 94025 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-07 |
| Decision Date | 2015-12-04 |
| Summary: | summary |