K822371 is an FDA 510(k) clearance for the MICRO WORKTABLE. This device is classified as a Block, Cutting, Ent, Sterile (Class I - General Controls, product code JXS).
Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982, 34 days after receiving the submission on August 6, 1982.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3540.
| 510(k) Number | K822371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1982 |
| Decision Date | September 09, 1982 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | JXS — Block, Cutting, Ent, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.3540 |