The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Entellus Medical Flexible Endoscope And Eyepiece.
| Device ID | K082569 |
| 510k Number | K082569 |
| Device Name: | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Entellus Medical, Inc. 18555 37TH AVENUE NORTH Plymouth, MN 55446 |
| Contact | Sew-wah Tay |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-05 |
| Decision Date | 2008-09-18 |
| Summary: | summary |