FDA.report

510(k) K832986

Device
PAP SMEAR BRUSH
Applicant
DONALD G. ZELLER
510(k) number
K832986
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-10
Date received
1983-09-01
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

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

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20888937009914Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.2016-09-21
20888937009907Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.2016-09-21
20888937009891Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.2016-09-21
30888937003230Cytobrush Plus GT ScoredCoopersurgical, Inc.2016-09-21
30888937003223Cytobrush Plus GTCoopersurgical, Inc.2016-09-21
30888937003216Cytobrush Plus GTCoopersurgical, Inc.2016-09-21
30888937003209Cytobrush Plus GTCoopersurgical, Inc.2016-09-21
30888937003193Cytobrush PlusCoopersurgical, Inc.2016-09-21
30888937003186Cytobrush PlusCoopersurgical, Inc.2016-09-21
30888937003179Cytobrush PlusCoopersurgical, Inc.2016-09-21
30888937003285Cytobrush Plus GTCoopersurgical, Inc.2016-08-25
30888937003278Cytobrush PlusCoopersurgical, Inc.2016-08-25

Legacy Summary

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FDA Review

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