The following data is part of a premarket notification filed by Bionic Instrument Corp. with the FDA for Klein Wire Tightener/bionic Wire.
| Device ID | K833726 |
| 510k Number | K833726 |
| Device Name: | KLEIN WIRE TIGHTENER/BIONIC WIRE |
| Classification | Twister, Wire |
| Applicant | BIONIC INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HXS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-24 |
| Decision Date | 1983-12-22 |