The following data is part of a premarket notification filed by Ortho Technology with the FDA for Multi Adjustable Face Mask.
| Device ID | K000358 |
| 510k Number | K000358 |
| Device Name: | MULTI ADJUSTABLE FACE MASK |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa, FL 33647 |
| Contact | Brian Leaghty |
| Correspondent | Brian Leaghty ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa, FL 33647 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-04 |
| Decision Date | 2000-06-09 |