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510(k) K103349

BACKSTOP CATHETER by Pluromed, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2011
Date Received
November 16, 2010
Clearance Type
Abbreviated
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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  • K090430 — BACKSTOP AND BACKSTOP INJECTOR (June 2, 2009)
  • K090270 — BACKSTOP CATHETER, MODEL 60-0000-3100 (May 15, 2009)

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