The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Sinojet Maxillary Sinus Puncture & Irrigation System.
| Device ID | K942495 |
| 510k Number | K942495 |
| Device Name: | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM |
| Classification | Cannula, Sinus |
| Applicant | ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1995-02-21 |