The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for Sinusway Dilation System.
| Device ID | K181838 |
| 510k Number | K181838 |
| Device Name: | Sinusway Dilation System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | 3NT Medical Ltd. 22 Hamelacha Street PO Box 11384 Rosh Ha'ayin, IL 4809169 |
| Contact | Ehud Bendory |
| Correspondent | Orly Maor Orly Maor 25 Sirkin Street Kfar Saba, IL 44421 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-10 |
| Decision Date | 2018-12-20 |
| Summary: | summary |