NaviENT

Neurological Stereotaxic Instrument

ClaroNav Inc.

The following data is part of a premarket notification filed by Claronav Inc. with the FDA for Navient.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540209955105	K163439	000
07540209955099	K163439	000