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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K844199
Device Name ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
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
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/30/1984
Decision Date 11/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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