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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 K040328
Device Name 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact ROSANNA SEVERINI
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact ROSANNA SEVERINI
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/10/2004
Decision Date 11/24/2004
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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