3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS


Device Classification Name

catheter, retention type, balloon

510(k) Number K022287
Device Name 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
Original Applicant
3T MEDICAL SYSTEMS, LLC.
12553 s. wamblee valley rd.
conifer, 
CO 
80433 -6204

Original Contact robert p eaton
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 07/15/2002
Decision Date 09/23/2002
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