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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 K033054
Device Name HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
Applicant
HARVARD CLINICAL TECHNOLOGY
22 PLEASANT ST.
SOUTH NATICK,  MA  01760
Applicant Contact ERIC J FLACHBART
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact SUSAN A GILL
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
FRN  
Date Received09/29/2003
Decision Date 12/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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