FDA.report

510(k) K890848

Device
CERVEX-BRUSH
Applicant
UNIMAR, INC.
510(k) number
K890848
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-11
Date received
1989-02-21
Regulation
884.4530
Classification name
Spatula, Cervical, Cytological
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ANTHONY HEMMING
Address
475 Danbury Rd. Wilton CT US 06897 06897

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20888937014390Cervex-BrushCoopersurgical, Inc.2016-09-30

Legacy Summary

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FDA Review

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