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510(k) K110491

BACKSTOP CATHETER by Pluromed, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2011
Date Received
February 22, 2011
Clearance Type
Special
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

Other clearances by Pluromed, Inc.

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  • K090270 — BACKSTOP CATHETER, MODEL 60-0000-3100 (May 15, 2009)

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