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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Shunt
510(k) Number K893679
Device Name SHUNT CONNECTORS
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
FJQ  
Date Received05/16/1989
Decision Date 07/24/1989
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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