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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 K880775
Device Name CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
Applicant
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Applicant Contact TOM BONNER
Correspondent
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Correspondent Contact TOM BONNER
Regulation Number876.5540
Classification Product Code
LFK  
Date Received02/26/1988
Decision Date 07/25/1988
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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