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FDA 510(k)

BREATH ACE BREATHFRESHENER

K-Number: K972131 · 1997-07-18

ApplicantBeyond 21st Century, Inc.
Decision Date1997-07-18
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BREATH ACE BREATHFRESHENER is the device name listed in this FDA 510(k) record. The listed applicant is Beyond 21st Century, Inc.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K972131. The device is classified under product code LCN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATH ACE BREATHFRESHENER?

BREATH ACE BREATHFRESHENER is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Beyond 21st Century, Inc.. The 510(k) number is K972131.

When did BREATH ACE BREATHFRESHENER receive FDA 510(k) clearance?

BREATH ACE BREATHFRESHENER received FDA 510(k) clearance on 1997-07-18, under 510(k) number K972131.

Who is the listed applicant for BREATH ACE BREATHFRESHENER?

The FDA 510(k) record lists Beyond 21st Century, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATH ACE BREATHFRESHENER?

The FDA product code for BREATH ACE BREATHFRESHENER is LCN.

Related Clinical Trials

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Related Devices (Code: LCN)

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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