K830821 is an FDA 510(k) clearance for the MICRO-MITT. This device is classified as a Cover, Shoe, Operating-room (Class I - General Controls, product code FXP).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on April 27, 1983, 43 days after receiving the submission on March 15, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K830821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1983 |
| Decision Date | April 27, 1983 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FXP — Cover, Shoe, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |