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FDA 510(k)

SPECTRASHIELD 9500 SURGICAL MASK

K-Number: K090414 · 2011-02-24

ApplicantNexera Medical, Inc.
Decision Date2011-02-24
Product CodeONT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRASHIELD 9500 SURGICAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Nexera Medical, Inc.. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K090414. The device is classified under product code ONT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRASHIELD 9500 SURGICAL MASK?

SPECTRASHIELD 9500 SURGICAL MASK is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Nexera Medical, Inc.. The 510(k) number is K090414.

When did SPECTRASHIELD 9500 SURGICAL MASK receive FDA 510(k) clearance?

SPECTRASHIELD 9500 SURGICAL MASK received FDA 510(k) clearance on 2011-02-24, under 510(k) number K090414.

Who is the listed applicant for SPECTRASHIELD 9500 SURGICAL MASK?

The FDA 510(k) record lists Nexera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRASHIELD 9500 SURGICAL MASK?

The FDA product code for SPECTRASHIELD 9500 SURGICAL MASK is ONT.

Related Clinical Trials

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Other records listing Nexera Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR

Related Devices (Code: ONT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122702BIOFRIEND BIOMASK N95 SURGICAL RESPIRATORFilligent LimitedK120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.K093161ACTIPROTECT UF N95 RESPIRATORGlaxosmithkline Consumer HealthcareK081923ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLDGlaxosmithkline Consumer Healthcare

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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