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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 K885339
Device Name FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
Applicant
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/28/1988
Decision Date 03/01/1989
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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