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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K920579
Device Name LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
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 Number876.5980
Classification Product Code
KNT  
Date Received02/10/1992
Decision Date 07/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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