The following data is part of a premarket notification filed by Medical Products & Research, Inc. with the FDA for Jaw Fixation Assembly.
| Device ID | K863799 |
| 510k Number | K863799 |
| Device Name: | JAW FIXATION ASSEMBLY |
| Classification | Lock, Wire, And Ligature, Intraoral |
| Applicant | MEDICAL PRODUCTS & RESEARCH, INC. 333 NORTH BELT, SUITE 1030 Houston, TX 77060 |
| Contact | Smith, Jr |
| Correspondent | Smith, Jr MEDICAL PRODUCTS & RESEARCH, INC. 333 NORTH BELT, SUITE 1030 Houston, TX 77060 |
| Product Code | DYX |
| CFR Regulation Number | 872.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-29 |
| Decision Date | 1986-10-14 |