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FDA 510(k)

TRELEX NATURAL(R) MESH

K-Number: K945377 · 1994-12-08

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1994-12-08
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRELEX NATURAL(R) MESH is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1994-12-08 under 510(k) number K945377. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRELEX NATURAL(R) MESH?

TRELEX NATURAL(R) MESH is a medical device that received FDA 510(k) clearance on 1994-12-08. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K945377.

When did TRELEX NATURAL(R) MESH receive FDA 510(k) clearance?

TRELEX NATURAL(R) MESH received FDA 510(k) clearance on 1994-12-08, under 510(k) number K945377.

Who is the listed applicant for TRELEX NATURAL(R) MESH?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRELEX NATURAL(R) MESH?

The FDA product code for TRELEX NATURAL(R) MESH is FTL.

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Other records listing Meadox Medicals, Div. Boston Scientific Corp. as applicant

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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