ORAL POTENTIAL METER (OPM)— 510(k) K982105

Name: FDA 510(k) clearance K982105
Creator: U.S. Food and Drug Administration
Published: 1998-09-16

Substantially Equivalent

Pertec of Wisconsin, Inc.

FDA 510(k) clearance K982105 for ORAL POTENTIAL METER (OPM), Substantially Equivalent on 1998-09-16. Applicant: Pertec of Wisconsin, Inc.. Device class: 2.

Clearance details

Applicant: Pertec of Wisconsin, Inc.
Product code: Code LFC
Device class: Class 2
Regulation: 21 CFR 872.1740
Advisory panel: Dental
Date received: 1998-06-16
Decision date: 1998-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suring, WI, US

Download summary PDF View on FDA.gov ↗

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