FDA.report

510(k) K895675

Device
PAP SMEAR TRAY
Applicant
INTL. CYTOBRUSH, INC.
510(k) number
K895675
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-11
Date received
1989-09-20
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
TSE, PH.D.
Address
P.O. Box 7733 Hollywood FL US 33081 33081

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
60888937009950Medscand Pap-Perfect Supply Tray Coopersurgical, Inc.2016-09-21

Legacy Summary

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FDA Review

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