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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 K843975
Device Name 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE
Applicant
Superior Plastic Products Corp.
Columbia Industrial Park
Cumberland,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
Superior Plastic Products Corp.
Columbia Industrial Park
Cumberland,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/11/1984
Decision Date 11/20/1984
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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