The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Novashield Injectable Nasal Packing And Stent.
| Device ID | K141704 |
| 510k Number | K141704 |
| Device Name: | NOVASHIELD INJECTABLE NASAL PACKING AND STENT |
| Classification | Splint, Intranasal Septal |
| Applicant | MEDTRONIC INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32259 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha MEDTRONIC INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32259 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-10-06 |
| Summary: | summary |