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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(k) Number K935781
Device Name ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Applicant Contact DENNIS POZZO
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Correspondent Contact DENNIS POZZO
Regulation Number876.5980
Classification Product Code
FEG  
Date Received12/06/1993
Decision Date 01/27/1995
Decision Substantially Equivalent - Kit (SESK)
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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