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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 K913661
Device Name MODIFIED VOLUMETRIC INFUSION PUMP
Applicant
MCGAW, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713 -9791
Applicant Contact JOHN G D'ANGELO
Correspondent
MCGAW, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713 -9791
Correspondent Contact JOHN G D'ANGELO
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received08/02/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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