FOSSA URETERAL OPEN STENTS


Device Classification Name

stent, ureteral

510(k) Number K072293
Device Name FOSSA URETERAL OPEN STENTS
Applicant
FOSSA MEDICAL, INC.
50 redfield street
boston, 
MA 
02122

Applicant Contact gloria kolb
Correspondent
FOSSA MEDICAL, INC.
50 redfield street
boston, 
MA 
02122

Correspodent Contact gloria kolb
Regulation Number 876.4620
Classification Product Code
FAD  
Date Received 08/16/2007
Decision Date 08/06/2008
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

Yes