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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K760761
Device Name ESOPHAGEAL MOTILITY TUBE
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 Number876.1725
Classification Product Code
FFX  
Date Received10/04/1976
Decision Date 11/30/1976
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
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