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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name irrigator, ostomy
510(k) Number K760810
Device Name TUBE, GASTRO-ENTEROSTOMY
Applicant
SHERWOOD MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHERWOOD MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5895
Classification Product Code
EXD  
Date Received10/02/1976
Decision Date 02/28/1977
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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