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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
510(k) Number K911289
Device Name EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
Applicant
BAXTER HEALTHCARE CORP.
198 LONDONDERRY TPKE
HOOKSETT,  NH  03106
Applicant Contact DIANE T ADINOLFO
Correspondent
BAXTER HEALTHCARE CORP.
198 LONDONDERRY TPKE
HOOKSETT,  NH  03106
Correspondent Contact DIANE T ADINOLFO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/25/1991
Decision Date 05/21/1991
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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