The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for 3nt Endoscopy System.
| Device ID | K162916 |
| 510k Number | K162916 |
| Device Name: | 3NT Endoscopy System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-02-24 |
| Summary: | summary |