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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 K813526
Device Name FECAL SANITARY TUBE
Applicant
Leon'S Fecal Sanitary Tub Mfg.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Leon'S Fecal Sanitary Tub Mfg.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/16/1981
Decision Date 01/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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