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510(k) K103371

COUDE/ OR TIEMANN by Degania Silicone , Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
November 17, 2010
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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