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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 K121032
Device Name PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact Yuliya Matlin
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact Yuliya Matlin
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/05/2012
Decision Date 06/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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