TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET


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

Correspodent Contact aaron compton
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/13/2011
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