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FDA 510(k)

RESOLUT REGENERATIVE MATERIAL

K-Number: K932866 · 1995-03-28

ApplicantW. L. Gore & Associates, Inc.
Decision Date1995-03-28
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESOLUT REGENERATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1995-03-28 under 510(k) number K932866. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLUT REGENERATIVE MATERIAL?

RESOLUT REGENERATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 1995-03-28. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K932866.

When did RESOLUT REGENERATIVE MATERIAL receive FDA 510(k) clearance?

RESOLUT REGENERATIVE MATERIAL received FDA 510(k) clearance on 1995-03-28, under 510(k) number K932866.

Who is the listed applicant for RESOLUT REGENERATIVE MATERIAL?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLUT REGENERATIVE MATERIAL?

The FDA product code for RESOLUT REGENERATIVE MATERIAL is LYC.

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Other records listing W. L. Gore & Associates, 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: LYC)

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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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