The following data is part of a premarket notification filed by Medtronic Xomed Inc. with the FDA for Alar Nasal Valve Stent.
| Device ID | K151758 |
| 510k Number | K151758 |
| Device Name: | ALAR Nasal Valve Stent |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MEDTRONIC XOMED INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 |
| Contact | Gabriela Anchondo |
| Correspondent | Gabriela Anchondo MEDTRONIC XOMED INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2015-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169700899 | K151758 | 000 |
| 20763000038186 | K151758 | 000 |
| 20643169232000 | K151758 | 000 |