The following data is part of a premarket notification filed by Silimed, Inc. with the FDA for Silimed Pectoral Implant.
| Device ID | K042054 |
| 510k Number | K042054 |
| Device Name: | SILIMED PECTORAL IMPLANT |
| Classification | Elastomer, Silicone Block |
| Applicant | SILIMED, INC. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith SILIMED, INC. PO BOX 4341 Crofton, MD 21114 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2005-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790023189 | K042054 | 000 |
| 00812790023172 | K042054 | 000 |
| 00812790023165 | K042054 | 000 |
| 00812790023158 | K042054 | 000 |
| 00812790023141 | K042054 | 000 |
| 00812790023134 | K042054 | 000 |