510(k) K131404

FLASH AR PENTA / FLASH AR PENTA QUICK by 3M Deutschland GmbH — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2013
Date Received
May 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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