The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Disposable Intra-articular Blade.
| Device ID | K830434 |
| 510k Number | K830434 |
| Device Name: | DISPOSABLE INTRA-ARTICULAR BLADE |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-09 |
| Decision Date | 1983-04-12 |