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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 K023264
Device Name MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/30/2002
Decision Date 12/19/2002
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
Recalls CDRH Recalls
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