The following data is part of a premarket notification filed by Norcliff Thayer, Inc. with the FDA for Brace (orafix Special).
| Device ID | K890290 |
| 510k Number | K890290 |
| Device Name: | BRACE (ORAFIX SPECIAL) |
| Classification | Unit, Syringe, Air And/or Water |
| Applicant | NORCLIFF THAYER, INC. 303 SOUTH BROADWAY Tarrytown, NY 10591 |
| Contact | Roberts, M.d. |
| Correspondent | Roberts, M.d. NORCLIFF THAYER, INC. 303 SOUTH BROADWAY Tarrytown, NY 10591 |
| Product Code | ECB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-19 |
| Decision Date | 1989-03-29 |