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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 K900148
Device Name KIT PAK IRRIGATION TRAY
Applicant
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Applicant Contact THOMAS J SANDERS
Correspondent
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Correspondent Contact THOMAS J SANDERS
Regulation Number876.5980
Classification Product Code
EYN  
Date Received01/11/1990
Decision Date 04/23/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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