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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K952810
Device Name DOSI-FLOW, MODELS 20 & 30
Applicant
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Applicant Contact JOAQUIM SORIANO
Correspondent
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Correspondent Contact JOAQUIM SORIANO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/19/1995
Decision Date 09/08/1995
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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