The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Em Ent Navigated Suctions.
| Device ID | K153555 |
| 510k Number | K153555 |
| Device Name: | EM ENT Navigated Suctions |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | Carey Brenner |
| Correspondent | Carey Brenner MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169702905 | K153555 | 000 |
| 00763000054120 | K153555 | 000 |
| 00763000054144 | K153555 | 000 |
| 00763000053369 | K153555 | 000 |
| 00763000053383 | K153555 | 000 |
| 00763000053390 | K153555 | 000 |
| 00643169702851 | K153555 | 000 |
| 00643169702868 | K153555 | 000 |
| 00643169702875 | K153555 | 000 |
| 00643169702882 | K153555 | 000 |
| 00643169702899 | K153555 | 000 |
| 00763000054137 | K153555 | 000 |