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FDA 510(k)

GUIDOR BIORESORBABLE MATRIX BARRIER

K-Number: K132325 · 2013-10-29

ApplicantSunstar Americas, Inc.
Decision Date2013-10-29
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUIDOR BIORESORBABLE MATRIX BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Sunstar Americas, Inc.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K132325. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDOR BIORESORBABLE MATRIX BARRIER?

GUIDOR BIORESORBABLE MATRIX BARRIER is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is Sunstar Americas, Inc.. The 510(k) number is K132325.

When did GUIDOR BIORESORBABLE MATRIX BARRIER receive FDA 510(k) clearance?

GUIDOR BIORESORBABLE MATRIX BARRIER received FDA 510(k) clearance on 2013-10-29, under 510(k) number K132325.

Who is the listed applicant for GUIDOR BIORESORBABLE MATRIX BARRIER?

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

What is the FDA product code for GUIDOR BIORESORBABLE MATRIX BARRIER?

The FDA product code for GUIDOR BIORESORBABLE MATRIX BARRIER is NPK.

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Other records listing Sunstar Americas, Inc. as applicant

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Related Devices (Code: NPK)

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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