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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 K933870
Device Name VIBA-BRUSH
Applicant
Rovers B.V.
15 # Mill St.
Nyack,  NY  10960
Applicant Contact THOMAS J SWIFT
Correspondent
Rovers B.V.
15 # Mill St.
Nyack,  NY  10960
Correspondent Contact THOMAS J SWIFT
Regulation Number884.4530
Classification Product Code
HHT  
Date Received08/06/1993
Decision Date 01/05/1995
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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