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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 K123943
Device Name AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
Applicant
Ameco Medical Industries
Arazy Group
57 Lazy Brook Rd.
Monroe,  CT  03468
Applicant Contact Ray Kelly
Correspondent
Ameco Medical Industries
Arazy Group
57 Lazy Brook Rd.
Monroe,  CT  03468
Correspondent Contact Ray Kelly
Regulation Number876.5540
Classification Product Code
MSD  
Date Received12/20/2012
Decision Date 04/02/2013
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
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