510(k) K031207

SAFETY RELEASE ARCH BAR KIT by Casey Surgical, LLC — Product Code DYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2003
Date Received
April 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lock, Wire, And Ligature, Intraoral
Device Class
Class II
Regulation Number
872.4600
Review Panel
DE
Submission Type