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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K022287
Device Name 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
Applicant
3t Medical Systems, LLC
12553 S. Wamblee Valley Rd.
Conifer,  CO  80433 -6204
Applicant Contact ROBERT P EATON
Correspondent
3t Medical Systems, LLC
12553 S. Wamblee Valley Rd.
Conifer,  CO  80433 -6204
Correspondent Contact ROBERT P EATON
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/15/2002
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
Predetermined Change
Control Plan Authorized		 No
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