The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Novapak Nasal Sinus Packing And Stent.
| Device ID | K202623 |
| 510k Number | K202623 |
| Device Name: | Novapak Nasal Sinus Packing And Stent |
| Classification | Splint, Intranasal Septal |
| Applicant | Medtronic Xomed 6743 Southpoint Drive North Jacksonville, FL 32256 |
| Contact | Matthew Harmon |
| Correspondent | Matthew Harmon Medtronic Xomed 6743 Southpoint Drive North Jacksonville, FL 32256 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-10 |
| Decision Date | 2020-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169662254 | K202623 | 000 |
| 00643169662247 | K202623 | 000 |
| 00643169662230 | K202623 | 000 |
| 00643169662223 | K202623 | 000 |