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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 K971586
Device Name DIGENE CERVICAL BRUSH
Applicant
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Applicant Contact CONSTANCE A FINCH
Correspondent
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Correspondent Contact CONSTANCE A FINCH
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/01/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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