The following data is part of a premarket notification filed by Stryker Ent with the FDA for Sinusprime Dilation System.
| Device ID | K201398 |
| 510k Number | K201398 |
| Device Name: | SINUSPRIME Dilation System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2020-10-15 |