FDA.report

510(k) K994253

Device
VACLOK SYRINGE
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K994253
Product code
FMF  
Decision
Substantially Equivalent (SESE)
Decision date
2000-01-05
Date received
1999-12-17
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHESTER MCCOY
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers

Source Documents

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

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Legacy Summary

summary

FDA Review

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