100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K030107
Device Name 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760 -1537

Original Contact jennifer johnson
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 01/13/2003
Decision Date 03/21/2003
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls