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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 K930955
Device Name CERVEX-BRUSH
Applicant
Rovers B.V.
108 Union St.
Rockaway,  NJ  07866
Applicant Contact JOHN RICHARDSON
Correspondent
Rovers B.V.
108 Union St.
Rockaway,  NJ  07866
Correspondent Contact JOHN RICHARDSON
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/23/1993
Decision Date 05/24/1994
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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