The following data is part of a premarket notification filed by Ortho Organizers, Inc. with the FDA for Nitanium Pro Form Archwires,round,square,rectangul.
| Device ID | K931663 |
| 510k Number | K931663 |
| Device Name: | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ORTHO ORGANIZERS, INC. 1619 SOUTH RANCHO SANTA FE RD. San Marcos, CA 92069 |
| Contact | Chuck Tyrrell |
| Correspondent | Chuck Tyrrell ORTHO ORGANIZERS, INC. 1619 SOUTH RANCHO SANTA FE RD. San Marcos, CA 92069 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1993-07-08 |