The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Sinovent Maxillary Sinus Drainage System.
| Device ID | K896630 |
| 510k Number | K896630 |
| Device Name: | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM |
| Classification | Cannula, Sinus |
| Applicant | ATOS MEDICAL AB 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | R. J Slomoff |
| Correspondent | R. J Slomoff ATOS MEDICAL AB 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-22 |
| Decision Date | 1990-06-06 |