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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
510(k) Number K780471
Device Name GASTRIC LAVAGE KIT
Applicant
GAYMAR INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GAYMAR INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5365
Classification Product Code
FAT  
Date Received03/24/1978
Decision Date 06/02/1978
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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