FDA.report

510(k) K031065

Device
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
Applicant
SYRINGEX MEDICAL, INC.
510(k) number
K031065
Product code
MEG  
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-23
Date received
2003-04-03
Regulation
880.5860
Classification name
Syringe, Antistick
Medical specialty
General Hospital
Review panel
General Hospital
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
JOHN JONES
Address
2311 Bear Hills Ct. Draper UT US 84020 84020

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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