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510(k) K051667

EZ-JECT by Indolor, Ltd. — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2005
Date Received
June 22, 2005
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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