CURE CATHETER CLOSED SYSTEM


Device Classification Name

catheter, urological

510(k) Number K080881
Device Name CURE CATHETER CLOSED SYSTEM
Applicant
CURE MEDICAL LLC.
29442 pointe royal
laguna niguel, 
CA 
92677

Applicant Contact james smith
Regulation Number 876.5130
Classification Product Code
KOD  
Subsequent Product Code
FCM  
Date Received 03/31/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

Yes