The following data is part of a premarket notification filed by Propel Orthodontics Llc. with the FDA for Propel Device.
| Device ID | K150392 |
| 510k Number | K150392 |
| Device Name: | PROPEL Device |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | PROPEL ORTHODONTICS LLC. 384 SOUTH ABBOTT AVENUE Milpitas, CA 95035 |
| Contact | Bryce Way |
| Correspondent | Craig J Coombs COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852673007059 | K150392 | 000 |
| 00852673007035 | K150392 | 000 |
| 00852673007028 | K150392 | 000 |
| 00852673007004 | K150392 | 000 |