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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 K811061
Device Name AUTOMATED GASTRIC LAVAGE
Applicant
EMERGENCY MEDICINE
1631 CITATION DRIVE
LIBRARY,  PA  15129 -
Applicant Contact JOSEPH P RUDOLPH
Correspondent
EMERGENCY MEDICINE
1631 CITATION DRIVE
LIBRARY,  PA  15129 -
Correspondent Contact JOSEPH P RUDOLPH
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/17/1981
Decision Date 06/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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