FDA.report

510(k) K930955

Device
CERVEX-BRUSH
Applicant
ROVERS B.V.
510(k) number
K930955
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-24
Date received
1993-02-23
Regulation
884.4530
Classification name
Spatula, Cervical, Cytological
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN RICHARDSON
Address
108 Union St. Rockaway NJ US 07866 07866

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
28719189246395Rovers® Cervex-Brush®Rovers Medical Devices B.V.2023-07-12
08719189246261Rovers® Cervex-Brush® Rovers Medical Devices B.V.2023-07-12
08719189246506Rovers® Cervex-Brush®Rovers Medical Devices B.V.2019-09-11
08719189246247Rovers® Cervex-Brush® RTRovers Medical Devices B.V.2018-07-16
00187207000290RoversAndwin Scientific2017-11-01
87191892462546Rovers® Cervex-Brush® RTRovers Medical Devices B.V.2017-10-20
87191892466018Rovers® Cervex-Brush®Rovers Medical Devices B.V.2017-10-20
08719189246056Rovers® Cervex-Brush® Rovers Medical Devices B.V.2017-10-19
87191892460566Rovers® Cervex-Brush® Rovers Medical Devices B.V.2016-10-03
87191892460252Rovers® Cervex-Brush®Rovers Medical Devices B.V.2016-10-03
87191892460016Rovers® Cervex-Brush®Rovers Medical Devices B.V.2016-10-03
00613647000595FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.2016-09-29
10382904905245ROVERS® CERVEX-BRUSH® TRIPATH IMAGING, INC.2016-09-24

Legacy Summary

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FDA Review

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