The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Sinuscope.
| Device ID | K170285 |
| 510k Number | K170285 |
| Device Name: | AED Sinuscope |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | National Advanced Endoscopy Devices, Inc. 22134 Sherman Way Canoga Park, CA 91303 |
| Contact | Gayle Butler |
| Correspondent | Gayle Butler National Advanced Endoscopy Devices, Inc. 22134 Sherman Way Canoga Park, CA 91303 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-08-01 |
| Summary: | summary |