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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, i.v.
510(k) Number K111217
Device Name ADDITIVE CAP
Applicant
BAXTER HEALTHCARE CORP.
1620 WAULKEGAN RD.
MCGAW PARK,  IL  60085 -6730
Applicant Contact NANETTE HEDDEN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAULKEGAN RD.
MCGAW PARK,  IL  60085 -6730
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received05/02/2011
Decision Date 06/14/2011
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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