FDA.report

510(k) K823297

Device
ST-610 NEEDLESCOPE STERILIZATION TRAY
Applicant
MEDIGROUP
510(k) number
K823297
Product code
HET  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-06
Date received
1982-11-05
Regulation
884.1720
Classification name
Laparoscope, Gynecologic (and Accessories)
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
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
00884450260609Y-TEC®Merit Medical Systems, Inc.2016-10-10
00884450170144Y-TEC®Merit Medical Systems, Inc.2016-10-10

Legacy Summary

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FDA Review

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