The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Entellus Medical Rs-series System.
| Device ID | K072302 |
| 510k Number | K072302 |
| Device Name: | ENTELLUS MEDICAL RS-SERIES SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Entellus Medical, Inc. 10200 73RD. AVE. NORTH SUTIE 122 Maple Grove, MN 55369 |
| Contact | Tom Ressemann |
| Correspondent | Tom Ressemann Entellus Medical, Inc. 10200 73RD. AVE. NORTH SUTIE 122 Maple Grove, MN 55369 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2008-04-08 |
| Summary: | summary |