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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Dialysis, Single Needle (Co-Axial Flow)
510(k) Number K904433
Device Name DUAL LUMEN NEEDLES
Applicant
Akcess Medical Products, Inc.
789 Jersey Ave.
New Brunswick,  NJ  08901
Applicant Contact BALBIR KAPANY
Correspondent
Akcess Medical Products, Inc.
789 Jersey Ave.
New Brunswick,  NJ  08901
Correspondent Contact BALBIR KAPANY
Regulation Number876.5540
Classification Product Code
LBW  
Date Received09/28/1990
Decision Date 11/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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