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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, Elastomeric
510(k) Number K062457
Device Name INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
Applicant
Baxter Healthcare Corporation
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corporation
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5725
Classification Product Code
MEB  
Date Received08/23/2006
Decision Date 09/21/2006
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
Recalls CDRH Recalls
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