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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 K810156
Device Name ARGYLE SALEM SUMP TUBE
Applicant
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/21/1981
Decision Date 03/02/1981
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
Recalls CDRH Recalls
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