FDA.report

510(k) K991794

Device
ENDOSCOPIC SPINAL ACCESS SYSTEM
Applicant
ENDIUS, INC.
510(k) number
K991794
Product code
HRX  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-13
Date received
1999-05-26
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
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
SUSAN FINNERAN
Address
23 W. Bacon St. Plainville MA US 02762 02762

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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