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510(k) K072005

RK EPIDURAL NEEDLE by Epimed International — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2008
Date Received
July 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

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