FDA.reportPublic FDA data

510(k) K024178

Device
VIATORR ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
510(k) number
K024178
Product code
JCT
Decision
Substantially Equivalent (SESE)
Decision date
2003-03-07
Date received
2002-12-18
Regulation
878.3720
Classification name
Prosthesis, Tracheal, Expandable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JACQUELINE KALBACH
Address
3450 W. Kiltie Ln. Flagstaff AZ US 86001 86001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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