K141704 is an FDA 510(k) clearance for the NOVASHIELD INJECTABLE NASAL PACKING AND STENT. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Medtronic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 6, 2014, 104 days after receiving the submission on June 24, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K141704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2014 |
| Decision Date | October 06, 2014 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LYA — Splint, Intranasal Septal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4780 |