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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 K904518
Device Name VOLUMETRIC INFUSION PUMP
Applicant
KENDALL MCGAW LABORATORIES, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713
Applicant Contact JOHN D'ANGELO
Correspondent
KENDALL MCGAW LABORATORIES, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713
Correspondent Contact JOHN D'ANGELO
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received10/03/1990
Decision Date 10/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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