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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 K851671
Device Name GASTROINTESTINAL TUBE
Applicant
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Applicant Contact JOHN A STEEN
Correspondent
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Correspondent Contact JOHN A STEEN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/23/1985
Decision Date 06/14/1985
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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