FOSSA URETERAL OPEN LUMEN STENT


Device Classification Name

catheter, ureteral, gastro-urology

510(k) Number K033368
Device Name FOSSA URETERAL OPEN LUMEN STENT
Applicant
FOSSA MEDICAL, INC.
580 harrison ave., 4th fl.
boston, 
MA 
02118

Applicant Contact gloria kolb
Correspondent
FOSSA MEDICAL, INC.
580 harrison ave., 4th fl.
boston, 
MA 
02118

Correspodent Contact gloria kolb
Regulation Number 876.5130
Classification Product Code
EYB  
Date Received 10/21/2003
Decision Date 11/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No