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510(k) K042709

DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER by Tyco Healthcare — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2005
Date Received
September 30, 2004
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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  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)

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