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510(k) K090430

BACKSTOP AND BACKSTOP INJECTOR by Pluromed, Inc. — Product Code ONJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 2, 2009
Date Received: February 19, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dissolvable Gel For Preventing Ureteral Stone Migration
Device Class: Class II
Regulation Number: 876.4680
Review Panel: GU
Submission Type

For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.