510(k) K173155

Pakter Curved Needle Set by Cook Incorporated — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2018
Date Received
September 29, 2017
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