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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 K882918
Device Name KIM NASO-INTESTINAL TUBE
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact STEEN, PHD
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact STEEN, PHD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/12/1988
Decision Date 12/05/1988
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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