K913059 is an FDA 510(k) clearance for the A-DEC KNEEBREAK 1030 CHAIR. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on October 8, 1991, 90 days after receiving the submission on July 10, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K913059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1991 |
| Decision Date | October 08, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |