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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 K993524
Device Name ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
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 Received10/18/1999
Decision Date 08/01/2000
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
Predetermined Change
Control Plan Authorized		 No
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