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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 K924908
Device Name CELL COLLECTING BRUSH
Applicant
Anderson Winn Paper Co.
P.O. Box 7609
14937 San Fernando Mission Blv
Mission Hills,  CA  91345
Applicant Contact NED BUCKMAN
Correspondent
Anderson Winn Paper Co.
P.O. Box 7609
14937 San Fernando Mission Blv
Mission Hills,  CA  91345
Correspondent Contact NED BUCKMAN
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/30/1992
Decision Date 04/13/1993
Decision Substantially Equivalent - Kit (SESK)
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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