The following data is part of a premarket notification filed by Medtronic Xomed Inc. with the FDA for Sharpsite Ac Rigid Endsocope.
| Device ID | K173855 |
| 510k Number | K173855 |
| Device Name: | Sharpsite AC Rigid Endsocope |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Medtronic Xomed Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Contact | Shravan Chawla |
| Correspondent | Shravan Chawla Medtronic Xomed Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-04-20 |
| Summary: | summary |