The following data is part of a premarket notification filed by Claronav Inc. with the FDA for Navient.
| Device ID | K163439 |
| 510k Number | K163439 |
| Device Name: | NaviENT |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ClaroNav Inc. 1140 Sheppard Avenue West - Unit 10 Toronto, CA M3k 2a2 |
| Contact | Ahmad Kolahi |
| Correspondent | Ahmad Kolahi ClaroNav Inc. 1140 Sheppard Avenue West - Unit 10 Toronto, CA M3k 2a2 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540209955105 | K163439 | 000 |
| 07540209955099 | K163439 | 000 |
| 07540209955976 | K163439 | 000 |
| 07540209955112 | K163439 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NAVIENT 86174603 4860323 Live/Registered |
NAVIENT SOLUTIONS, LLC 2014-01-24 |
![]() NAVIENT 86171830 4860321 Live/Registered |
NAVIENT SOLUTIONS, LLC 2014-01-22 |
![]() NAVIENT 86171638 4860320 Live/Registered |
NAVIENT SOLUTIONS, LLC 2014-01-22 |