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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 K864106
Device Name SR-MODEL 230 (MODIFICATION)
Applicant
HIRATA SANGYO CO. USA, INC.
810 SOUTH SPRING ST., STE. 404
LOS ANGELES,  CA  90014
Applicant Contact KARL C BARTEL
Correspondent
HIRATA SANGYO CO. USA, INC.
810 SOUTH SPRING ST., STE. 404
LOS ANGELES,  CA  90014
Correspondent Contact KARL C BARTEL
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/21/1986
Decision Date 11/19/1986
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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