The following data is part of a premarket notification filed by Today's Machining & Design, Inc. with the FDA for Needle Bender Tx8225.
| Device ID | K834108 |
| 510k Number | K834108 |
| Device Name: | NEEDLE BENDER TX8225 |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | TODAY'S MACHINING & DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-29 |
| Decision Date | 1984-03-12 |