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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
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mcgaw Park,  IL  60085
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
Predetermined Change
Control Plan Authorized		 No
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