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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K020465
Device Name MEDCOMP ASH SPLIT-CATH II
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact FLORENCE A CAIKOSKI
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact FLORENCE A CAIKOSKI
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/12/2002
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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