510(k) K040098

VARNISHAMERICA by Medical Products Laboratories, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2004
Date Received
January 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type