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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 K851058
Device Name DOSI FLOW
Applicant
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Applicant Contact JUAN ALFONSO
Correspondent
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Correspondent Contact JUAN ALFONSO
Regulation Number880.5725
Classification Product Code
LDR  
Date Received03/14/1985
Decision Date 04/29/1985
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
Recalls CDRH Recalls
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