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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 K900852
Device Name MAGNET RETRIEVAL CATHETER
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/22/1990
Decision Date 05/02/1990
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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