510(k) K103164

VONFLEX HEAVY, VINFLEX LIGHT by Vericom Co., Ltd. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2010
Date Received
October 27, 2010
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