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510(k) K082138

AIRGENT, MODEL AG7000010 by Perfaction, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
July 29, 2008
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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