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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853622
Device Name SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
Applicant
Kleen Test Products
4425 W. Woolworth Ave.
P.O.B Ox 574
Milwaukee,  WI  53218
Applicant Contact RICK W POENITSCH
Correspondent
Kleen Test Products
4425 W. Woolworth Ave.
P.O.B Ox 574
Milwaukee,  WI  53218
Correspondent Contact RICK W POENITSCH
Date Received08/29/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
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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