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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, shunt
510(k) Number K892667
Device Name SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313
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
FKN  
Date Received04/13/1989
Decision Date 05/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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