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510(k) K122837

AUTOJECT 2 FOR GLASSY SYRINGE by Owen Mumford, Ltd. — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2012
Date Received
September 17, 2012
Clearance Type
Special
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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