RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM


Device Classification Name

prosthesis, esophageal

510(k) Number K030559
Device Name RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
Applicant
RUSCH INTL.
50 plantation dr.
jaffery, 
NH 
03452

Applicant Contact karenann j brozowski
Correspondent
RUSCH INTL.
50 plantation dr.
jaffery, 
NH 
03452

Correspodent Contact karenann j brozowski
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 02/21/2003
Decision Date 06/30/2003
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