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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 K983294
Device Name ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact LINDA COLEMAN
Correspondent
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact LINDA COLEMAN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received09/21/1998
Decision Date 11/03/1998
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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