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510(k) K022287

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS by 3t Medical Systems, LLC — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2002
Date Received
July 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by 3t Medical Systems, LLC

  • K072697 — 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (December 20, 2007)
  • K020768 — 3T VESSEL CANNULAS (August 23, 2002)
  • K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (May 3, 2002)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)

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