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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 K111351
Device Name TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
Applicant
Us Infusion Dba Truecare Biomedix
2003 NW 79th Ave.
Miami,  FL  33122
Applicant Contact AARON COMPTON
Correspondent
Us Infusion Dba Truecare Biomedix
2003 NW 79th Ave.
Miami,  FL  33122
Correspondent Contact AARON COMPTON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/13/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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