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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 K150513
Device Name Imed Technology Intravascular Administration Set, Imed Technology Extension Set
Applicant
IMED TECHNOLOGY, INC.
2544 TARPLEY RD. STE 112
CARROLLTON,  TX  75006
Applicant Contact KYLE ADAMS
Correspondent
IMED TECHNOLOGY, INC.
2544 TARPLEY RD. STE 112
CARROLLTON,  TX  75006
Correspondent Contact KYLE ADAMS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/27/2015
Decision Date 05/28/2015
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
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