The following data is part of a premarket notification filed by Jeffrey H. Attlin with the FDA for Remoldable Craniomandibular Appliance.
| Device ID | K833455 |
| 510k Number | K833455 |
| Device Name: | REMOLDABLE CRANIOMANDIBULAR APPLIANCE |
| Classification | Positioner, Tooth, Preformed |
| Applicant | JEFFREY H. ATTLIN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1984-01-10 |