510(k) K000722

UNIPOLAR NEEDLES by Pajunk GmbH — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2000
Date Received
March 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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