COUDE/ OR TIEMANN


Device Classification Name

catheter, retention type, balloon

510(k) Number K103371
Device Name COUDE/ OR TIEMANN
Applicant
DEGANIA SILICONE, LTD.
degania bet
emek hayarden, 

IL

15130

Applicant Contact zoya lee
Correspondent
DEGANIA SILICONE, LTD.
degania bet
emek hayarden, 

IL

15130

Correspodent Contact zoya lee
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 11/17/2010
Decision Date 03/11/2011
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