510(k) K110092

TAKE 1 ADVANCED RIGID TRAY by Kerr Corporation — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2011
Date Received
January 12, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type