WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM


Device Classification Name

prosthesis, esophageal

510(k) Number K073266
Device Name WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact neil kelly
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact neil kelly
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 11/20/2007
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No