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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy, Suction
510(k) Number K895900
Device Name WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Applicant Contact RICHARD F MARSHALL
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Correspondent Contact RICHARD F MARSHALL
Regulation Number876.1075
Classification Product Code
FCK  
Date Received10/06/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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