The following data is part of a premarket notification filed by Spirox, Inc. with the FDA for Latera Absorbable Nasal Implant.
| Device ID | K161191 |
| 510k Number | K161191 |
| Device Name: | Latera 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857037006921 | K161191 | 000 |
| 00857037006082 | K161191 | 000 |
| 00857037006044 | K161191 | 000 |
| 00857037006983 | K161191 | 000 |
| 00857037006990 | K161191 | 000 |
| 00857037006105 | K161191 | 000 |
| 00857037006075 | K161191 | 000 |