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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K022209
Device Name ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
Applicant
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact RENNE L FLUET
Correspondent
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact RENNE L FLUET
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LHI  
Date Received07/08/2002
Decision Date 08/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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