UROSURGE SPIRALFLO URETERAL STENT


Device Classification Name

stent, ureteral

510(k) Number K992391
Device Name UROSURGE SPIRALFLO URETERAL STENT
Applicant
UROSURGE, INC.
2660 crosspark rd.
coralville, 
IA 
52241

Applicant Contact steven j preiss
Correspondent
UROSURGE, INC.
2660 crosspark rd.
coralville, 
IA 
52241

Correspodent Contact steven j preiss
Regulation Number 876.4620
Classification Product Code
FAD  
Date Received 07/19/1999
Decision Date 08/18/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No