POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330


Device Classification Name

prosthesis, esophageal

510(k) Number K080332
Device Name POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact ashley pyle
Correspondent
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact ashley pyle
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 02/07/2008
Decision Date 09/05/2008
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