FDA.report

510(k) K982819

Device
ENDIUS SPINE ENDOSCOPE
Applicant
ENDIUS, INC.
510(k) number
K982819
Product code
GWG  
Decision
Substantially Equivalent (SESE)
Decision date
1999-01-27
Date received
1998-08-11
Regulation
882.1480
Classification name
Endoscope, Neurological
Medical specialty
Neurology
Review panel
Neurology
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
JOSEPH RESS
Address
45 Pontiac Rd. Newton MA US 02468 02468

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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