The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Calf Implant.
| Device ID | K974480 |
| 510k Number | K974480 |
| Device Name: | SILIMED CALF 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 |
|---|---|---|
| 00812790022953 | K974480 | 000 |
| 00812790022946 | K974480 | 000 |
| 00812790022939 | K974480 | 000 |
| 00812790022922 | K974480 | 000 |
| 00812790022915 | K974480 | 000 |
| 00812790022908 | K974480 | 000 |
| 00812790022892 | K974480 | 000 |
| 00812790022885 | K974480 | 000 |
| 00812790022878 | K974480 | 000 |