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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 K944351
Device Name SMARTDOSE IV PREFILLED INFUSION CONTAINER
Applicant
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Applicant Contact MARK SHANNON
Correspondent
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Correspondent Contact MARK SHANNON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/06/1994
Decision Date 11/15/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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