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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 K922382
Device Name INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact PATRICIA S BARSANTI
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact PATRICIA S BARSANTI
Regulation Number880.5725
Classification Product Code
MEB  
Date Received05/20/1992
Decision Date 02/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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