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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name guide, needle, surgical
510(k) Number K900903
Device Name KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
Applicant
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Applicant Contact ROBERT SHAW
Correspondent
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Correspondent Contact ROBERT SHAW
Regulation Number878.4800
Classification Product Code
GDF  
Date Received02/27/1990
Decision Date 05/03/1990
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
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