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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K890098
Device Name KLEEN TEST O.R. KIT
Applicant
Kleen Test Products
P.O. Box 140
Elkhorn,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
Kleen Test Products
P.O. Box 140
Elkhorn,  WI  53121
Correspondent Contact GARY L SWANSON
Regulation Number878.4370
Classification Product Code
LRO  
Date Received01/10/1989
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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