ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium— 510(k) K201309

Name: FDA 510(k) clearance K201309
Creator: U.S. Food and Drug Administration
Published: 2021-06-04

Substantially Equivalent

Mecta Corporation

FDA 510(k) clearance K201309 for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium, Substantially Equivalent on 2021-06-04. Applicant: Mecta Corporation. Device class: 2.

Clearance details

Applicant: Mecta Corporation
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 2020-05-15
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tualatin, OR, US

Download summary PDF View on FDA.gov ↗

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