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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 K140884
Device Name SYMETREX LONG TERM HEMODIALYSIS CATHETER
Applicant
PHASE ONE MEDICAL
55 NORTHERN BLVD SUITE 200
GREAT NECK,  NY  11021
Applicant Contact ADITYA SUKTHANKAR
Correspondent
PHASE ONE MEDICAL
55 NORTHERN BLVD SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact ADITYA SUKTHANKAR
Regulation Number876.5540
Classification Product Code
MSD  
Date Received04/07/2014
Decision Date 11/26/2014
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
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