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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K882628
Device Name ENDO C BRUSH
Applicant
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Applicant Contact MILGROM
Correspondent
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Correspondent Contact MILGROM
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/27/1988
Decision Date 07/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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