FDA.report

510(k) K951898

Device
VERSA-VU
Applicant
COOPERSURGICAL, INC.
510(k) number
K951898
Product code
HIB  
Decision
Substantially Equivalent (SESE)
Decision date
1995-12-11
Date received
1995-04-24
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
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN CHAPMAN
Address
15 Forest Pkwy. Shelton CT US 06484 06484

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00888937000115Prima Series® Vaginal SpeculumCoopersurgical, Inc.2016-09-28
00888937000078Prima Series® Vaginal SpeculumCoopersurgical, Inc.2016-09-28

Legacy Summary

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FDA Review

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