FDA.report

510(k) K080359

Device
EVOLUTION ESOPHAGEAL STENT SYSTEM
Applicant
Cook Ireland, Ltd.
510(k) number
K080359
Product code
ESW
Decision
Substantially Equivalent (SESE)
Decision date
2008-05-09
Date received
2008-02-11
Regulation
878.3610
Classification name
Prosthesis, Esophageal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
NOREEN BARRY
Address
O' Halloran Rd., National Technology Park Limerick IE

FDA Registration Numbers

Source Documents

510(k) summary PDF

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