K994262 is an FDA 510(k) clearance for the FRONTAL SINUS TREPHINATION CANNULA. This device is classified as a Cannula, Sinus (Class I - General Controls, product code KAM).
Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 8, 2000, 53 days after receiving the submission on December 17, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K994262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1999 |
| Decision Date | February 08, 2000 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KAM — Cannula, Sinus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |