The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Nasal Retainer.
| Device ID | K980221 |
| 510k Number | K980221 |
| Device Name: | SILIMED NASAL RETAINER |
| Classification | Splint, Intranasal Septal |
| Applicant | SILIMED, LLC. P.O BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith SILIMED, LLC. P.O BOX 4341 Crofton, MD 21114 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-22 |
| Decision Date | 1998-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790023462 | K980221 | 000 |
| 00812790023370 | K980221 | 000 |
| 00812790023387 | K980221 | 000 |
| 00812790023394 | K980221 | 000 |
| 00812790023400 | K980221 | 000 |
| 00812790023417 | K980221 | 000 |
| 00812790023424 | K980221 | 000 |
| 00812790023431 | K980221 | 000 |
| 00812790023448 | K980221 | 000 |
| 00812790023455 | K980221 | 000 |
| 00812790023356 | K980221 | 000 |