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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 K890848
Device Name CERVEX-BRUSH
Applicant
UNIMAR, INC.
475 DANBURY RD.
WILTON,  CT  06897
Applicant Contact ANTHONY HEMMING
Correspondent
UNIMAR, INC.
475 DANBURY RD.
WILTON,  CT  06897
Correspondent Contact ANTHONY HEMMING
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/21/1989
Decision Date 05/11/1989
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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