ENDOMAXX FULLY COVERED ESOPHAGEAL STENT


Device Classification Name

prosthesis, esophageal

510(k) Number K111611
Device Name ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095 -2415

Applicant Contact john c knorpp
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095 -2415

Correspodent Contact john c knorpp
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 06/09/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No