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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 K944882
Device Name IRRIGATION TRAY
Applicant
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Applicant Contact DAVID INSCO
Correspondent
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Correspondent Contact DAVID INSCO
Regulation Number876.5980
Classification Product Code
EYN  
Date Received10/03/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
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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