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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dual lumen ecmo cannula
510(k) Number K203409
Device Name MC3 Crescent Jugular Dual Lumen Catheter
MC3, Inc.
2555 Bishop Circle West
dexter,  MI  48130
Applicant Contact martha rumford
MC3, Inc.
2555 Bishop Circle West
dexter,  MI  48130
Correspondent Contact martha rumford
Regulation Number870.4100
Classification Product Code
Date Received11/19/2020
Decision Date 05/03/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No