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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 K972678
Device Name MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
Applicant
MCGAW, INC.
2525 MCGAW AVE.
IRVINE,  CA  92714 -5895
Applicant Contact REBECCA STOLARICK
Correspondent
MCGAW, INC.
2525 MCGAW AVE.
IRVINE,  CA  92714 -5895
Correspondent Contact REBECCA STOLARICK
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received07/16/1997
Decision Date 10/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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