HANAROSTENT BILIARY (NNN)


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K111149
Device Name HANAROSTENT BILIARY (NNN)
Applicant
M.I. TECH CO., LTD.
1733 canton lane
marietta, 
GA 
30062

Applicant Contact paul sumner
Correspondent
M.I. TECH CO., LTD.
1733 canton lane
marietta, 
GA 
30062

Correspodent Contact paul sumner
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 04/25/2011
Decision Date 12/30/2011
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No