NITI-S BILIARY STENT


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K073667
Device Name NITI-S BILIARY 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 876.5010
Classification Product Code
FGE  
Date Received 12/26/2007
Decision Date 11/19/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No