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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 K941472
Device Name CERVEX-BRUSH PAP KIT
Applicant
Rovers Diagnostic Devices
15 # Mill St.
Nyack,  NY  10960
Applicant Contact THOMAS J SWIFT
Correspondent
Rovers Diagnostic Devices
15 # Mill St.
Nyack,  NY  10960
Correspondent Contact THOMAS J SWIFT
Regulation Number884.4530
Classification Product Code
HHT  
Date Received03/28/1994
Decision Date 02/28/1995
Decision Substantially Equivalent - Kit (SESK)
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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