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FDA 510(k)

TEPHAFLEX SURGICAL MESH

K-Number: K070894 · 2007-04-13

ApplicantTepha, Inc.
Decision Date2007-04-13
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEPHAFLEX SURGICAL 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 2007-04-13 under 510(k) number K070894. The device is classified under product code OOD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEPHAFLEX SURGICAL MESH?

TEPHAFLEX SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Tepha, Inc.. The 510(k) number is K070894.

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

TEPHAFLEX SURGICAL MESH received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070894.

Who is the listed applicant for TEPHAFLEX SURGICAL 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 SURGICAL MESH?

The FDA product code for TEPHAFLEX SURGICAL MESH is OOD.

Related Clinical Trials

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Other records listing Tepha, 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.

K233999GalaFLEX LITE ScaffoldK202425SurgiLattice scaffoldK211307GalaSTITCH Absorbable Monofilament SutureK162922GalaFORM 3DK161092GalaSHAPE 3DK132348TEPHAFLEX BRAIDED SUTURE

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Related Devices (Code: OOD)

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.

K233999GalaFLEX LITE ScaffoldTepha, Inc.K202425SurgiLattice scaffoldTepha, Inc.K162922GalaFORM 3DTepha, Inc.K161424Phasix MeshC.R. Bard, Inc.K161092GalaSHAPE 3DTepha, Inc.K130326TEPHAFLEX MELTBLOWN CONSTRUCTTepha, 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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