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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K233394
Device Name Gem Flow Now (GEM2770-FN)
Applicant
Synovis Micro Companies Alliance
(A Subsidiary Of Baxter International Inc.)
439 Industrial Lane
Birmingham,  AL  35211
Applicant Contact Julie Carlston
Correspondent
Synovis Micro Companies Alliance
(A Subsidiary Of Baxter International Inc.)
439 Industrial Lane
Birmingham,  AL  35211
Correspondent Contact Julie Carlston
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received10/03/2023
Decision Date 01/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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