510(k) K171577

Smartcord, Smartcord X by Eastdent Co., Ltd. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2018
Date Received
May 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type