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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 K851821
Device Name VI-FLOW PUMP WITH VI-SET
Applicant
Vital Canada, Inc.
1316 Rosseau Pl.
Burlington, Ont. Canada,  CA L7P33N2
Applicant Contact LE MARE
Correspondent
Vital Canada, Inc.
1316 Rosseau Pl.
Burlington, Ont. Canada,  CA L7P33N2
Correspondent Contact LE MARE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/26/1985
Decision Date 07/05/1985
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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