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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 K823195
Device Name GASTRIC LAVAGE KIT
Applicant
AUTOVAGE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AUTOVAGE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/26/1982
Decision Date 12/03/1982
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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