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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, infusion line
510(k) Number K113227
Device Name NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
Original Applicant
BAXTER HEALTHCARE CORP.
1 baxter pkwy.
deerfield,  IL  60015
Original Contact nanette hedden
Regulation Number880.5440
Classification Product Code
FPB  
Date Received11/01/2011
Decision Date 12/08/2011
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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