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510(k) K042557

INNOJECT AUTO-INJECTOR by Innoject, Inc. — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2004
Date Received
September 20, 2004
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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