The following data is part of a premarket notification filed by Pmt Corporation with the FDA for Allura Vaginal Stent.
| Device ID | K202542 |
| 510k Number | K202542 |
| Device Name: | Allura Vaginal Stent |
| Classification | Stent, Vaginal |
| Applicant | PMT Corporation 1500 Park Road Chanhassen, MN 55317 |
| Contact | Matt Cree |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KXP |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-09-02 |
| Decision Date | 2020-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650551002666 | K202542 | 000 |
| 00650551002284 | K202542 | 000 |
| 00650551002277 | K202542 | 000 |
| 00650551002260 | K202542 | 000 |
| 00650551002253 | K202542 | 000 |
| 00650551002246 | K202542 | 000 |
| 00650551002239 | K202542 | 000 |
| 00650551002222 | K202542 | 000 |
| 00650551002758 | K202542 | 000 |