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510(k) K082815

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS by Well Lead Medical Instruments — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
September 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K042684 — WELL LEAD TRACHEOSTOMY TUBE (February 17, 2005)

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