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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Long Term Support Greater Than 6 Hours
510(k) Number K232767
Device Name Nautilus VF ECMO Oxygenator
Applicant
Mc3, Inc.
2555 Bishop Circle W
Dexter,  MI  48130
Applicant Contact Martha Rumford
Correspondent
Mc3, Inc.
2555 Bishop Circle W
Dexter,  MI  48130
Correspondent Contact Martha Rumford
Regulation Number870.4100
Classification Product Code
BYS  
Date Received09/11/2023
Decision Date 10/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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