Crystal Vision

Apparatus, Exhaust, Surgical

I.C MEDICAL, INC.

The following data is part of a premarket notification filed by I.c Medical, Inc. with the FDA for Crystal Vision.

Pre-market Notification Details

• Device ID: K163659
• 510k Number: K163659
• Device Name: Crystal Vision
• Classification: Apparatus, Exhaust, Surgical
• Applicant: I.C MEDICAL, INC. 2340 W. SHANGRI LA RD. Phoenix, AZ 85029
• Contact: Elena S. Buiga
• Correspondent: Elena S. Buiga; I.C MEDICAL, INC. 2340 W. SHANGRI LA RD. Phoenix, AZ 85029
• Product Code: FYD
• CFR Regulation Number: 878.5070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-27
• Decision Date: 2017-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817688021896	K163659	000
00817688021889	K163659	000