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510(k) K182013

Device
EasyInstruments
Applicant
Agency For Medical Innovations GmbH
510(k) number
K182013
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-11
Date received
2018-07-27
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Martin Hohlrieder
Address
Im Letten 1 Feldkirch AT 6800 6800

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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