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510(k) K080881

CURE CATHETER CLOSED SYSTEM by Cure Medical, LLC — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2008
Date Received
March 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Cure Medical, LLC

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  • K072539 — CURE CATHETER (September 13, 2007)

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