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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, vessel
510(k) Number K910502
Device Name VESSEL DILATORS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
789 JERSEY AVE.
NEW BRUNSWICK,  NJ  08901
Applicant Contact BALBIR B KAPANY
Correspondent
AKCESS MEDICAL PRODUCTS, INC.
789 JERSEY AVE.
NEW BRUNSWICK,  NJ  08901
Correspondent Contact BALBIR B KAPANY
Regulation Number876.5540
Classification Product Code
FKA  
Date Received02/05/1991
Decision Date 04/29/1991
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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