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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 K873746
Device Name AUTO SYRINGE MODEL AS20G INFUSION PUMP
Applicant
BAXTER HEALTHCARE CORP.
198 LONDONDERRY TPKE
HOOKSETT,  NH  03106
Applicant Contact ROGER A LEROUX
Correspondent
BAXTER HEALTHCARE CORP.
198 LONDONDERRY TPKE
HOOKSETT,  NH  03106
Correspondent Contact ROGER A LEROUX
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/16/1987
Decision Date 01/06/1988
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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