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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 K921050
Device Name ULTRAFLO RATESAVER PLUS INFUSION PUMP
Applicant
CLINICAL SYSTEMS, INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
CLINICAL SYSTEMS, INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/05/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
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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