WALLSTENT ENTERNAL PROSTHESIS


Device Classification Name

stent, colonic, metalic, expandable

510(k) Number K000281
Device Name WALLSTENT ENTERNAL PROSTHESIS
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact lisa m quaglia
Regulation Number 878.3610
Classification Product Code
MQR  
Subsequent Product Code
MUM  
Date Received 01/31/2000
Decision Date 05/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No