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FDA 510(k)

EQUIMATRIX

K-Number: K111816 · 2011-09-29

ApplicantLuitpold Pharmaceuticals, Inc.
Decision Date2011-09-29
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EQUIMATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Luitpold Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111816. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUIMATRIX?

EQUIMATRIX is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Luitpold Pharmaceuticals, Inc.. The 510(k) number is K111816.

When did EQUIMATRIX receive FDA 510(k) clearance?

EQUIMATRIX received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111816.

Who is the listed applicant for EQUIMATRIX?

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

What is the FDA product code for EQUIMATRIX?

The FDA product code for EQUIMATRIX is NPM.

Related Clinical Trials

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Other records listing Luitpold Pharmaceuticals, 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.

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Related Devices (Code: NPM)

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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