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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K891753
Device Name DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
Applicant
AKCESS MEDICAL PRODUCTS, INC.
789 JERSEY AVE.
NEW BRUNSWICK,  NJ  08901
Applicant Contact EDWARD J HOPKINS
Correspondent
AKCESS MEDICAL PRODUCTS, INC.
789 JERSEY AVE.
NEW BRUNSWICK,  NJ  08901
Correspondent Contact EDWARD J HOPKINS
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received03/23/1989
Decision Date 06/08/1989
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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