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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, A-V Shunt
510(k) Number K842039
Device Name ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
Applicant
Argon Medical Corp.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact DAVE BARANSKI
Correspondent
Argon Medical Corp.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact DAVE BARANSKI
Regulation Number876.5540
Classification Product Code
KNZ  
Date Received05/21/1984
Decision Date 01/29/1985
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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