The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Endodontic Broach-barbed Broach.
| Device ID | K823489 |
| 510k Number | K823489 |
| Device Name: | ENDODONTIC BROACH-BARBED BROACH |
| Classification | Broach, Endodontic |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKW |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1982-12-15 |