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510(k) K893438

Device
T SERIES VESSEL TIPS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
510(k) number
K893438
Product code
FKW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-08
Date received
1989-05-03
Regulation
876.5540
Classification name
Tip, Vessel
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
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 FKW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K810257VESSEL TIPS, SIZES 13-18Quinton, Inc.1981-03-13
K791645VICKERS MEDICAL MODEL 112 TREONIC DC2Vickers America Medical Corp.1979-10-02

Legacy Summary#

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FDA Review#

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