FDA.report

510(k) K920803

Device
HSG TRAY
Applicant
UNIMAR, INC.
510(k) number
K920803
Product code
HIB  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1992-10-19
Date received
1992-02-21
Regulation
884.4530
Classification name
Speculum, Vaginal, Nonmetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
EDWARD C VOLLMER
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
20888937003264HSG TrayCoopersurgical, Inc.2016-07-29

Legacy Summary

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FDA Review

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