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510(k) K810370

Device
POLLACK CHAIN CYSOURETHROGRAM SET
Applicant
VANCE PRODUCTS, INC.
510(k) number
K810370
Product code
FGI  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-20
Date received
1981-02-12
Regulation
876.5130
Classification name
Catheter, Urethrographic, Male
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K023019VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000Vomed Volzer Medizintechnik GmbH & Co.2002-12-10
K013360DFINER UROLOGICAL CATHETERNeoseed Technology,Llc2002-02-20

Legacy Summary#

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FDA Review#

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