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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, Non-Implanted
510(k) Number K983511
Device Name SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JEANNE M CUSH
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JEANNE M CUSH
Regulation Number876.5540
Classification Product Code
MPB  
Date Received10/07/1998
Decision Date 06/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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