510(k) K982105

ORAL POTENTIAL METER (OPM) by Pertec of Wisconsin, Inc. — Product Code LFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1998
Date Received
June 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Caries Detection
Device Class
Class II
Regulation Number
872.1740
Review Panel
DE
Submission Type