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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 K822565
Device Name NEEDLE CATHETER JEJUNOSTOMY KIT
Applicant
Bio-Research Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bio-Research Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/22/1982
Decision Date 09/28/1982
Decision Substantially Equivalent (SESE)
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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