The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Gluteal Implant.
| Device ID | K974482 |
| 510k Number | K974482 |
| Device Name: | SILIMED GLUTEAL IMPLANT |
| Classification | Elastomer, Silicone Block |
| 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 | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790023127 | K974482 | 000 |
| 00812790022977 | K974482 | 000 |
| 00812790022984 | K974482 | 000 |
| 00812790022991 | K974482 | 000 |
| 00812790023004 | K974482 | 000 |
| 00812790023011 | K974482 | 000 |
| 00812790023028 | K974482 | 000 |
| 00812790023035 | K974482 | 000 |
| 00812790023042 | K974482 | 000 |
| 00812790023059 | K974482 | 000 |
| 00812790023066 | K974482 | 000 |
| 00812790023073 | K974482 | 000 |
| 00812790023080 | K974482 | 000 |
| 00812790023097 | K974482 | 000 |
| 00812790023103 | K974482 | 000 |
| 00812790023110 | K974482 | 000 |
| 00812790022960 | K974482 | 000 |