BACKSTOP CATHETER


Device Classification Name

catheter, urological

510(k) Number K103349
Device Name BACKSTOP CATHETER
Applicant
PLUROMED, INC.
25-h olympia avenue
woburn, 
MA 
01801

Applicant Contact james wilkie
Correspondent
PLUROMED, INC.
25-h olympia avenue
woburn, 
MA 
01801

Correspodent Contact james wilkie
Regulation Number 876.5130
Classification Product Code
KOD  
Date Received 11/16/2010
Decision Date 01/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No