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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 K041241
Device Name MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
Applicant
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact STACY L LEWIS
Correspondent
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact STACY L LEWIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/11/2004
Decision Date 07/06/2004
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
Recalls CDRH Recalls
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