The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Meropack Bioresorbable Nasal Packing And Sinus Stent.
| Device ID | K041381 |
| 510k Number | K041381 |
| Device Name: | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT |
| Classification | Splint, Intranasal Septal |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David S Dodd |
| Correspondent | David S Dodd MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-25 |
| Decision Date | 2004-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885074137791 | K041381 | 000 |
| 20885074137777 | K041381 | 000 |