K041381 is an FDA 510(k) clearance for the MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 10, 2004, 108 days after receiving the submission on May 25, 2004.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K041381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2004 |
| Decision Date | September 10, 2004 |
| Days to Decision | 108 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 |