The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Xpress Balloon Device.
| Device ID | K102003 |
| 510k Number | K102003 |
| Device Name: | XPRESS BALLOON DEVICE |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Contact | Karen Peterson |
| Correspondent | Karen Peterson Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-10-22 |
| Summary: | summary |