The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Nasal L Shaped Implant.
| Device ID | K981833 |
| 510k Number | K981833 |
| Device Name: | SILIMED NASAL L SHAPED IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| 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 | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790023202 | K981833 | 000 |
| 00812790023196 | K981833 | 000 |