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FDA 510(k)

NASALGUARD

K-Number: K053625 · 2006-02-22

ApplicantTrutek Corp
Decision Date2006-02-22
Product CodeNUP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NASALGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Trutek Corp. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K053625. The device is classified under product code NUP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASALGUARD?

NASALGUARD is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Trutek Corp. The 510(k) number is K053625.

When did NASALGUARD receive FDA 510(k) clearance?

NASALGUARD received FDA 510(k) clearance on 2006-02-22, under 510(k) number K053625.

Who is the listed applicant for NASALGUARD?

The FDA 510(k) record lists Trutek Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASALGUARD?

The FDA product code for NASALGUARD is NUP.

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Related Devices (Code: NUP)

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.

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Official Source

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

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