The following data is part of a premarket notification filed by Entellus Medical Inc. with the FDA for Entellus Medical Reinforced Anesthesia Needle.
| Device ID | K163435 |
| 510k Number | K163435 |
| Device Name: | Entellus Medical Reinforced Anesthesia Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Entellus Medical Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Contact | Megan Bernier |
| Correspondent | Karen Peterson Entellus Medical Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857326005574 | K163435 | 000 |
| 00857326005550 | K163435 | 000 |
| 10857326005571 | K163435 | 000 |
| 10857326005557 | K163435 | 000 |