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510(k) K024018

AVANT GUARDIAN 101 by Avant Medical Corporation — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

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