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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter (gastric, colonic, etc.), irrigation and aspiration
510(k) Number K770248
Device Name ARGYLE RAPID GASTRIC LAVAGE KIT
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 Number876.5980
Classification Product Code
KDH  
Date Received02/07/1977
Decision Date 03/09/1977
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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