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510(k) K032848

MEDSAFE SYSTEM INSERTER by Medsolve Technologies, LLC — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2004
Date Received
September 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

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