K912418 is an FDA 510(k) clearance for the SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE. This device is classified as a Cannula, Sinus (Class I - General Controls, product code KAM).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 20, 1991, 203 days after receiving the submission on May 31, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K912418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1991 |
| Decision Date | December 20, 1991 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KAM — Cannula, Sinus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |