The following data is part of a premarket notification filed by American Safety Equipment Corp. with the FDA for Kirschner Wire.
| Device ID | K801010 |
| 510k Number | K801010 |
| Device Name: | KIRSCHNER WIRE |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | AMERICAN SAFETY EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-28 |
| Decision Date | 1980-05-20 |