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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, A-V Shunt
510(k) Number K840415
Device Name HEMOCATH
Applicant
Quinton, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact - -
Correspondent
Quinton, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact - -
Regulation Number876.5540
Classification Product Code
FIQ  
Date Received01/31/1984
Decision Date 04/20/1984
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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