CURE CATHETER


Device Classification Name

catheter, straight

510(k) Number K072539
Device Name CURE CATHETER
Applicant
CURE MEDICAL LLC.
28241 crown valley parkway
suite 510
laguna niguel, 
CA 
92677

Applicant Contact james smith
Regulation Number 876.5130
Classification Product Code
EZD  
Subsequent Product Code
GBM  
Date Received 09/10/2007
Decision Date 09/13/2007
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

No

Recalls CDRH Recalls