SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR— 510(k) K120244

Name: FDA 510(k) clearance K120244
Creator: U.S. Food and Drug Administration
Published: 2012-07-05

Substantially Equivalent

Nexera Medical, Inc.

FDA 510(k) clearance K120244 for SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR, Substantially Equivalent on 2012-07-05. Applicant: Nexera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nexera Medical, Inc.
Product code: Code ONT
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2012-01-27
Decision date: 2012-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft.Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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