SpectraShield 9500 Surgical N95 Respirator— 510(k) K150729

Substantially Equivalent

Nexera Medical, Inc.

FDA 510(k) clearance K150729 for SpectraShield 9500 Surgical N95 Respirator, Substantially Equivalent on 2015-12-29. Applicant: Nexera Medical, Inc..

Clearance details

Applicant: Nexera Medical, Inc.
Product code: Code ONT
Advisory panel: General, Plastic Surgery
Date received: 2015-03-20
Decision date: 2015-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft.Lauderdale, FL, US

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