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FDA 510(k)

COLLADENTAL BARRIER

K-Number: K100695 · 2013-01-03

ApplicantCollamatrix, Inc.
Decision Date2013-01-03
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLLADENTAL BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Collamatrix, Inc.. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K100695. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLADENTAL BARRIER?

COLLADENTAL BARRIER is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Collamatrix, Inc.. The 510(k) number is K100695.

When did COLLADENTAL BARRIER receive FDA 510(k) clearance?

COLLADENTAL BARRIER received FDA 510(k) clearance on 2013-01-03, under 510(k) number K100695.

Who is the listed applicant for COLLADENTAL BARRIER?

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

What is the FDA product code for COLLADENTAL BARRIER?

The FDA product code for COLLADENTAL BARRIER is NPL.

Related Clinical Trials

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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Other records listing Collamatrix, 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.

K093351COLLAWOUND ART

Related Devices (Code: NPL)

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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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