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510(k) K023019

Device
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
Applicant
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
510(k) number
K023019
Product code
FGI  
Decision
Substantially Equivalent (SESE)
Decision date
2002-12-10
Date received
2002-09-11
Regulation
876.5130
Classification name
Catheter, Urethrographic, Male
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAGMAR MASER
Address
152b Bridge St. Hot Springs NC US 28743 28743

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013360DFINER UROLOGICAL CATHETERNeoseed Technology,Llc2002-02-20
K810370POLLACK CHAIN CYSOURETHROGRAM SETVance Products, Inc.1981-03-20

Legacy Summary#

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FDA Review#

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