The following data is part of a premarket notification filed by Ortosim, S.a. De C.v. with the FDA for Morales Protraction Facemask.
| Device ID | K032392 |
| 510k Number | K032392 |
| Device Name: | MORALES PROTRACTION FACEMASK |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ORTOSIM, S.A. DE C.V. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ORTOSIM, S.A. DE C.V. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D864PLUS0 | K032392 | 000 |
| D864MINI0 | K032392 | 000 |
| D864ECOTROPIC0 | K032392 | 000 |
| D864ECO0 | K032392 | 000 |