MERIT MEDICAL 20 ML SYRINGE


Device Classification Name

syringe, piston

510(k) Number K111091
Device Name MERIT MEDICAL 20 ML SYRINGE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Applicant Contact michaela rivkowich
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Correspodent Contact michaela rivkowich
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 04/19/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No