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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 K142433
Device Name Hospira Extension Set
Applicant
Hospira, Inc.
375 Field Drive
Lake Forest,  IL  60045
Applicant Contact David Blonski
Correspondent
Hospira, Inc.
375 Field Drive
Lake Forest,  IL  60045
Correspondent Contact David Blonski
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/29/2014
Decision Date 12/08/2014
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
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