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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Irrigation, Sterile
510(k) Number K900737
Device Name PISTON IRRIGATION TRAY
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
EYN  
Date Received02/16/1990
Decision Date 04/19/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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