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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 K895417
Device Name ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.S
Reading,  PA  19610
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.S
Reading,  PA  19610
Correspondent Contact THOMAS D NICKEL
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received09/01/1989
Decision Date 01/03/1990
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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