The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Entellus Medical Balloon Device.
| Device ID | K093007 |
| 510k Number | K093007 |
| Device Name: | ENTELLUS MEDICAL BALLOON DEVICE |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Entellus Medical, Inc. 18555 37TH AVENUE NORTH Plymouth, MN 55446 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay Entellus Medical, Inc. 18555 37TH AVENUE NORTH Plymouth, MN 55446 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-02-05 |
| Summary: | summary |