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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter (gastric, colonic, etc.), irrigation and aspiration
510(k) Number K923497
Device Name FLUSHING IRRIGATION 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 Number876.5980
Classification Product Code
KDH  
Date Received07/15/1992
Decision Date 03/21/1994
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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