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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 K032233
Device Name MEDLEY PCA MODULE, MODEL 8120
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
san diego,  CA  92121
Applicant Contact stacey l lewis
Correspondent
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
san diego,  CA  92121
Correspondent Contact stacey l lewis
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
FRN  
Date Received07/21/2003
Decision Date 09/09/2003
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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