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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K880006
Device Name STA-SET I.V. FLOW REGULATOR
Applicant
Controlled Flow , Ltd.
12705 S. Kirkwood 220
Stafford,  TX  77477
Applicant Contact MATTHEW O'BOYLE
Correspondent
Controlled Flow , Ltd.
12705 S. Kirkwood 220
Stafford,  TX  77477
Correspondent Contact MATTHEW O'BOYLE
Regulation Number880.5725
Classification Product Code
LDR  
Date Received01/04/1988
Decision Date 03/24/1988
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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