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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 K890283
Device Name CYTEX ONE AND CYTEX TWO
Applicant
ANDERSON WINN PAPER CO.
1101 W. CHESTNUT ST.
BURBANK,  CA  91506
Applicant Contact ABNER LEVY
Correspondent
ANDERSON WINN PAPER CO.
1101 W. CHESTNUT ST.
BURBANK,  CA  91506
Correspondent Contact ABNER LEVY
Regulation Number884.4530
Classification Product Code
HHT  
Date Received01/19/1989
Decision Date 03/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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