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510(k) K082587

AUTO-SAFETY INJECTOR-2 (ASI-2) by Medical House Products Limited — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2008
Date Received
September 8, 2008
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

Other clearances by Medical House Products Limited

  • K060819 — COOL.CLICK 2 (June 16, 2006)

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