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510(k) K140953

GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER by Convatec, Ltd. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2014
Date Received
April 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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