K831117 is an FDA 510(k) clearance for the MICROMAT W/VARIOUS MODELS. This device is classified as a Pad, Kelly (Class II - Special Controls, product code FNW).
Submitted by Pmt, Inc. (Hopkins, US). The FDA issued a Cleared decision on May 30, 1984, 421 days after receiving the submission on April 5, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K831117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1983 |
| Decision Date | May 30, 1984 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FNW — Pad, Kelly |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |