VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM


Device Classification Name

cystoscope and accessories, flexible/rigid

510(k) Number K072180
Device Name VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
Applicant
VISION-SCIENCES, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Applicant Contact pamela papineau
Correspondent
VISION-SCIENCES, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Correspodent Contact pamela papineau
Regulation Number 876.1500
Classification Product Code
FAJ  
Subsequent Product Codes
FED   FFS  
Date Received 08/06/2007
Decision Date 12/18/2007
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