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510(k) K233394

Gem Flow Now (GEM2770-FN) by Synovis Micro Companies Alliance — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2024
Date Received
October 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Synovis Micro Companies Alliance

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  • K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM (February 1, 2010)
  • K040163 — MICROVASCULAR ANASTOMOTIC DEVICE (April 16, 2004)

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