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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 K040149
Device Name PSI-TEC PERISTALTIC INFILTRATION PUMP
Applicant
Byron Medical
602 W Rillito St.
Tucson,  AZ  85705
Applicant Contact REGINA S HARRIS
Correspondent
Byron Medical
602 W Rillito St.
Tucson,  AZ  85705
Correspondent Contact REGINA S HARRIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/23/2004
Decision Date 06/03/2004
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
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