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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 K111900
Device Name NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
Applicant
Teleflex Medical, Inc.
2400 BERNVILLE ROAD
READING,  PA  19605
Applicant Contact SUZANNE SCHORLE
Correspondent
Teleflex Medical, Inc.
2400 BERNVILLE ROAD
READING,  PA  19605
Correspondent Contact SUZANNE SCHORLE
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/05/2011
Decision Date 08/17/2011
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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