NITI-S ESOPHAGEAL STENT


Device Classification Name

prosthesis, esophageal

510(k) Number K080782
Device Name NITI-S ESOPHAGEAL STENT
Applicant
TAEWOONG MEDICAL CO., LTD
5536 trowbridge drive
dunwoody, 
GA 
30338

Applicant Contact cathryn n cambria
Correspondent
TAEWOONG MEDICAL CO., LTD
5536 trowbridge drive
dunwoody, 
GA 
30338

Correspodent Contact cathryn n cambria
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 03/19/2008
Decision Date 01/30/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No