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FDA 510(k) Application Details - K140270
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K140270
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
HEALTH LINE INTERNATIONAL CORPORATION
PO BOX 2786
ST. GEORGE, UT 84771-2786 US
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Contact
JOHN E LINCOLN
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
02/03/2014
Decision Date
08/20/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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