The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Vaginal Stent.
| Device ID | K974479 |
| 510k Number | K974479 |
| Device Name: | SILIMED VAGINAL STENT |
| Classification | Stent, Vaginal |
| 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 | KXP |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812790024940 | K974479 | 000 |
| 00812790024933 | K974479 | 000 |
| 00812790024926 | K974479 | 000 |
| 00812790024919 | K974479 | 000 |