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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 K880583
Device Name MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact RANDY WALLS
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact RANDY WALLS
Regulation Number876.5540
Classification Product Code
MPB  
Date Received02/09/1988
Decision Date 02/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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