510(k) K893679

Device
SHUNT CONNECTORS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
510(k) number
K893679
Product code
FJQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-07-24
Date received
1989-05-16
Regulation
876.5540
Classification name
Connector, Shunt
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BALBIR KAPANY
Address
789 Jersey Ave. New Brunswick NJ US 08901 08901

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771422PATIENT BY-PASSQuinton, Inc.1978-01-03
K771429DISP. TEFLON CONNHCTORQuinton, Inc.1977-12-22

Legacy Summary#

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FDA Review#

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