FDA.report

510(k) K840536

Device
CRYO SURG 5900
Applicant
FRIGITRONICS OF CONNECTICUT, INC.
510(k) number
K840536
Product code
GEH  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-23
Date received
1984-02-08
Regulation
878.4350
Classification name
Unit, Cryosurgical, Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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

Primary DIBrandCompanyPublished
00888937009743FrigitronicsCoopersurgical, Inc.2016-07-29

Legacy Summary

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FDA Review

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