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FDA 510(k)

TEPHAFLEX COMPOSITE MESH

K-Number: K101287 · 2010-08-30

ApplicantTepha, Inc.
Decision Date2010-08-30
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEPHAFLEX COMPOSITE MESH is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2010-08-30 under 510(k) number K101287. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEPHAFLEX COMPOSITE MESH?

TEPHAFLEX COMPOSITE MESH is a medical device that received FDA 510(k) clearance on 2010-08-30. The listed applicant is Tepha, Inc.. The 510(k) number is K101287.

When did TEPHAFLEX COMPOSITE MESH receive FDA 510(k) clearance?

TEPHAFLEX COMPOSITE MESH received FDA 510(k) clearance on 2010-08-30, under 510(k) number K101287.

Who is the listed applicant for TEPHAFLEX COMPOSITE MESH?

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

What is the FDA product code for TEPHAFLEX COMPOSITE MESH?

The FDA product code for TEPHAFLEX COMPOSITE MESH is OWT.

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Other records listing Tepha, Inc. as applicant

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Related Devices (Code: OWT)

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.

K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ Self-Gripping Resorbable MeshSofradim ProductionK191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific ABK191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K173143Phasix ST MeshC.R. Bard, Inc.

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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