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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 K955002
Device Name MAHURKAR 8 FR DUAL LEMEN CATHETER
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021 -8906
Applicant Contact LYNN LAYMAN-SPILLAR
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021 -8906
Correspondent Contact LYNN LAYMAN-SPILLAR
Regulation Number876.5540
Classification Product Code
MPB  
Date Received11/01/1995
Decision Date 09/13/1996
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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