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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
Applicant
Baxter Healthcare Corp
1 Baxter Pkwy.
Deerfield,  IL  60015
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corp
1 Baxter Pkwy.
Deerfield,  IL  60015
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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