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510(k) K071049

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR by Tyco Healthcare — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2007
Date Received
April 13, 2007
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

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  • K033453 — KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (April 29, 2004)
  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)

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