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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K890539
Device Name SURE COUNT LIGHT HANDLE COVER
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 Number878.4580
Classification Product Code
FTA  
Date Received02/03/1989
Decision Date 02/27/1989
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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