ARGOS

Device, Analysis, Anterior Segment

SANTEC CORPORATION

The following data is part of a premarket notification filed by Santec Corporation with the FDA for Argos.

Pre-market Notification Details

• Device ID: K191051
• 510k Number: K191051
• Device Name: ARGOS
• Classification: Device, Analysis, Anterior Segment
• Applicant: SANTEC CORPORATION 5823 Ohkusa-Nenjozaka Komaki, JP 485-0802
• Contact: Changho Chong
• Correspondent: Dave Yungvirt; THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
• Product Code: MXK
• CFR Regulation Number: 886.1850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2019-04-19
• Decision Date: 2019-05-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04573344510024	K191051	000