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510(k) K893478

Device
DA-16 AND DA-24 SHUNT ADAPTERS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
510(k) number
K893478
Product code
FKN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-08
Date received
1989-05-04
Regulation
876.5540
Classification name
Adaptor, Shunt
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 FKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K892667SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313Akcess Medical Products, Inc.1989-05-04
K813428SHUNT ADAPTERQuinton, Inc.1981-12-31
K771425A-V SHUNT EXTENSIONQuinton, Inc.1978-01-03

Legacy Summary#

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FDA Review#

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