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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 K942843
Device Name CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY
Applicant
ROVERS DIAGNOSTIC DEVICES
15 NO. MILL ST.
NYACK,  NY  10960
Applicant Contact THOMAS J SWIFT
Correspondent
ROVERS DIAGNOSTIC DEVICES
15 NO. MILL ST.
NYACK,  NY  10960
Correspondent Contact THOMAS J SWIFT
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/16/1994
Decision Date 12/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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