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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 K830119
Device Name NEEDLE CATHETER JEJUNOSTOMY KIT
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/11/1983
Decision Date 01/28/1983
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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