K860940 is an FDA 510(k) clearance for the MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT. This device is classified as a Unit, Examining/treatment, Ent (Class I - General Controls, product code ETF).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 2, 1986, 51 days after receiving the submission on March 12, 1986.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5300.
| 510(k) Number | K860940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1986 |
| Decision Date | May 02, 1986 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETF — Unit, Examining/treatment, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.5300 |