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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 Or Syringe, Extra-Luminal
510(k) Number K935461
Device Name VECTOR AMBULATORY DRUG DELIVERY SYSTEM
Applicant
INFUSION TECHNOLOGY INTL.
35 CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact PAUL FENTON
Correspondent
INFUSION TECHNOLOGY INTL.
35 CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact PAUL FENTON
Regulation Number876.5820
Classification Product Code
FIH  
Date Received11/12/1993
Decision Date 04/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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