510(k) K220505

Device
ATTIVA
Applicant
Italian Engineering S.R.L.
510(k) number
K220505
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-09
Date received
2022-02-22
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Elisabetta Tonelli
Address
Via Dell'Elettricista, 38 Bologna IT 40138 40138

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
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08058341213919RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)ITALIAN ENGINEERING SRL2023-03-28
05060224334010RF THERMOCOUPLE ELECTRODEITALIAN ENGINEERING SRL2023-03-28
05060224334003RF THERMOCOUPLE ELECTRODEITALIAN ENGINEERING SRL2023-03-28
05060224333990RF THERMOCOUPLE ELECTRODEITALIAN ENGINEERING SRL2023-03-28
05060224333983RF THERMOCOUPLE ELECTRODEITALIAN ENGINEERING SRL2023-03-28
08055510890087ATTIVAITALIAN ENGINEERING SRL2023-03-20
05060224334072INTERMEDIATE CABLEITALIAN ENGINEERING SRL2023-03-20

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