GEM FLOW COUPLER DEVICE AND SYSTEM

Device, Anastomotic, Microvascular

SYNOVIS MICRO COMPANIES ALLIANCE, INC.

The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Gem Flow Coupler Device And System.

Pre-market Notification Details

• Device ID: K093310
• 510k Number: K093310
• Device Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Classification: Device, Anastomotic, Microvascular
• Applicant: SYNOVIS MICRO COMPANIES ALLIANCE, INC. 2575 UNIVERSITY AVE. Saint Paul, MN 55114 -1024
• Contact: Melissa J Forth
• Correspondent: Melissa J Forth; SYNOVIS MICRO COMPANIES ALLIANCE, INC. 2575 UNIVERSITY AVE. Saint Paul, MN 55114 -1024
• Product Code: MVR
• CFR Regulation Number: 878.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-22
• Decision Date: 2010-02-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10844735005186	K093310	000
00844735005127	K093310	000
00844735005110	K093310	000