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FDA 510(k)

NATURA-TONE OR LUXOPAL CL ACRYLIC

K-Number: K842208 · 1984-07-31

ApplicantParexel Intl. Corp.
Decision Date1984-07-31
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NATURA-TONE OR LUXOPAL CL ACRYLIC is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1984-07-31 under 510(k) number K842208. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURA-TONE OR LUXOPAL CL ACRYLIC?

NATURA-TONE OR LUXOPAL CL ACRYLIC is a medical device that received FDA 510(k) clearance on 1984-07-31. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K842208.

When did NATURA-TONE OR LUXOPAL CL ACRYLIC receive FDA 510(k) clearance?

NATURA-TONE OR LUXOPAL CL ACRYLIC received FDA 510(k) clearance on 1984-07-31, under 510(k) number K842208.

Who is the listed applicant for NATURA-TONE OR LUXOPAL CL ACRYLIC?

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

What is the FDA product code for NATURA-TONE OR LUXOPAL CL ACRYLIC?

The FDA product code for NATURA-TONE OR LUXOPAL CL ACRYLIC is ELM.

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Related Devices (Code: ELM)

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

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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