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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 K914375
Device Name NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Applicant Contact DENNIS POZZA
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Correspondent Contact DENNIS POZZA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/01/1991
Decision Date 03/06/1992
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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