FDA.report

510(k) K952810

Device
DOSI-FLOW, MODELS 20 & 30
Applicant
LEVENTON, S.A.
510(k) number
K952810
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-08
Date received
1995-06-19
Regulation
880.5440
Classification name
Set, Administration, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOAQUIM SORIANO
Address
Poligono Can Suyer, 11 Sant Andreu De La Barca Barcelona ES 08740 08740

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
18436020769181DOSI-FLOWLEVENTON SAU2023-09-08
18436020769174DOSI-FLOWLEVENTON SAU2023-09-08
08436020769207DOSI-FLOWLEVENTON SAU2023-08-10
08436020768835DOSI-FLOWLEVENTON SAU2023-08-10
08436020768828DOSI-FLOWLEVENTON SAU2023-08-10
18436020761703DOSI-FLOWLEVENTON SAU2016-11-30
18436020764254DOSI-FLOWLEVENTON SAU2016-11-30
18436020763462DOSI-FLOWLEVENTON SAU2016-11-30
18436020761369DOSI-FLOWLEVENTON SAU2016-11-30
18436020760560DOSI-FLOWLEVENTON SAU2016-11-30

Legacy Summary

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FDA Review

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