FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT


Device Classification Name

stent, ureteral

510(k) Number K021140
Device Name FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
Original Applicant
FOSSA INDUSTRIES, INC.
580 harrison ave.,
4th floor
boston, 
MA 
02118

Original Contact gloria kolb
Regulation Number 876.4620
Classification Product Code
FAD  
Date Received 04/09/2002
Decision Date 06/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No