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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K153731
Device Name LifeFlow Rapid Infusion Device (LifeFlow Device)
Applicant
410 Medical Innovation, LLC
201 W. Main St., Suite 305
Durham,  NC  27701
Applicant Contact Galen Robertson
Correspondent
Full Circle Regulatory Consulting, LLC
201 W. Main St., Suite 305
Durham,  NC  27701
Correspondent Contact Dawn Reilly-O'Dell
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/28/2015
Decision Date 08/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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