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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Femoral
510(k) Number K854612
Device Name ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
Applicant
Med-West, Inc.
P.O. Box 26851
Salt Lake City,  UT  84126
Applicant Contact DAVE BEATTIE
Correspondent
Med-West, Inc.
P.O. Box 26851
Salt Lake City,  UT  84126
Correspondent Contact DAVE BEATTIE
Regulation Number876.5540
Classification Product Code
LFK  
Date Received11/18/1985
Decision Date 01/03/1986
Decision Substantially Equivalent - With Drug (SESD)
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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