The following data is part of a premarket notification filed by Osw Manufacturing, Llc with the FDA for Osw Aligner System.
| Device ID | K191990 |
| 510k Number | K191990 |
| Device Name: | OSW Aligner System |
| Classification | Aligner, Sequential |
| Applicant | OSW Manufacturing, LLC 35778 Elk Lane Murrieta, CA 92563 |
| Contact | Ian Kitching |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-07-25 |
| Decision Date | 2019-08-23 |