ORALLITE COMPREHENSIVE EXAM TRAY— 510(k) K012070

Substantially Equivalent

Trylon Corp.

FDA 510(k) clearance K012070 for ORALLITE COMPREHENSIVE EXAM TRAY, Substantially Equivalent on 2001-11-27. Applicant: Trylon Corp.. Device class: 2.

Clearance details

Applicant: Trylon Corp.
Product code: Code MPU
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2001-07-02
Decision date: 2001-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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