The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Wells Johnson Fixation System.
| Device ID | K945500 |
| 510k Number | K945500 |
| Device Name: | WELLS JOHNSON FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | WELLS JOHNSON CO. 075 E. RESEARCH CT, SUT. 101 P. O. BOX 18230 Tucson, AZ 85733 -8230 |
| Contact | Brenda Hunt |
| Correspondent | Brenda Hunt WELLS JOHNSON CO. 075 E. RESEARCH CT, SUT. 101 P. O. BOX 18230 Tucson, AZ 85733 -8230 |
| Product Code | JEY |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-09-21 |