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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K831347
Device Name MICROCAPILLARY INFUSION SYSTEM
Applicant
J.S. BIOMEDICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
J.S. BIOMEDICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/25/1983
Decision Date 06/02/1983
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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