K942495 is an FDA 510(k) clearance for the SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM. This device is classified as a Cannula, Sinus (Class I - General Controls, product code KAM).
Submitted by Atos Medical AB (Horby, Sweden, SE). The FDA issued a Cleared decision on February 21, 1995, 280 days after receiving the submission on May 17, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K942495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1994 |
| Decision Date | February 21, 1995 |
| Days to Decision | 280 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 |