The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Malar Implant.
| Device ID | K981835 |
| 510k Number | K981835 |
| Device Name: | SILIMED MALAR IMPLANT |
| Classification | Implant, Malar |
| 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 | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790023349 | K981835 | 000 |
| 00812790023332 | K981835 | 000 |
| 00812790023325 | K981835 | 000 |
| 00812790023318 | K981835 | 000 |
| 00812790023301 | K981835 | 000 |
| 00812790023295 | K981835 | 000 |