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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
Applicant Contact DENNIS POZZO
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
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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