FDA.report

510(k) K991758

Device
MONOJECT INSULIN SYRINGE
Applicant
THE KENDAL CO.
510(k) number
K991758
Product code
FMF  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-14
Date received
1999-05-24
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
FRANK J FUCILE
Address
15 Hampshire St. Mansfield MA US 02048 02048

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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