FDA.report

510(k) K983144

Device
FLEXPOSURE RETRACTOR
Applicant
ENDIUS, INC.
510(k) number
K983144
Product code
HRX  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-24
Date received
1998-09-08
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
MARY MCNAMARA-CULLINANE
Address
49 Plain St. North Attleboro MA US 02760 02760

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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