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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Pca
510(k) Number K051253
Device Name MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact NANETTE HEDDEN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
MEB  
Date Received05/16/2005
Decision Date 07/15/2005
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
Recalls CDRH Recalls
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