The following data is part of a premarket notification filed by Ortho Organizers, Inc. with the FDA for Stainless Steel Orthodontic Products.
| Device ID | K931980 |
| 510k Number | K931980 |
| Device Name: | STAINLESS STEEL ORTHODONTIC PRODUCTS |
| Classification | Band, Material, 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 | DYO |
| Subsequent Product Code | DZC |
| Subsequent Product Code | ECN |
| Subsequent Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-09-01 |