WIRED MOUTH PROTECTOR (WMP)— 510(k) K131396

Name: FDA 510(k) clearance K131396
Creator: U.S. Food and Drug Administration
Published: 2013-09-30

Substantially Equivalent

Elba Laboratories, Inc.

FDA 510(k) clearance K131396 for WIRED MOUTH PROTECTOR (WMP), Substantially Equivalent on 2013-09-30. Applicant: Elba Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Elba Laboratories, Inc.
Product code: Code PFL
Device class: Class 1
Regulation: 21 CFR 872.6890
Advisory panel: Dental
Date received: 2013-05-15
Decision date: 2013-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ferndale, MI, US

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