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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enema kit
510(k) Number K901179
Device Name ENEMA BUCKET SET
Applicant
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number876.5210
Classification Product Code
FCE  
Date Received03/13/1990
Decision Date 06/28/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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