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510(k) K090262

PERCUCATH URINARY CATHETER by Percuvision, LLC — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2009
Date Received
February 3, 2009
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

Other clearances by Percuvision, LLC

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  • K091600 — DIRECTVISION GUIDE SYSTEM (August 25, 2009)

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