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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 K860086
Device Name ENTERAL NUTRITION PUMPS PN 1000 AND VM 05
Applicant
Vial Medical , Ltd.
4515 Boul. Poirier
Ville St-Laurent (Quebec)
H4r 2a4 Canada,  CA
Applicant Contact BERNARD VILLATTE
Correspondent
Vial Medical , Ltd.
4515 Boul. Poirier
Ville St-Laurent (Quebec)
H4r 2a4 Canada,  CA
Correspondent Contact BERNARD VILLATTE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/09/1986
Decision Date 03/24/1986
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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