The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Finess Endoscope.
| Device ID | K102366 |
| 510k Number | K102366 |
| Device Name: | FINESS ENDOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2011-02-15 |
| Summary: | summary |