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FDA 510(k)

PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES

K-Number: K050187 · 2005-02-18

ApplicantSofradim Production
Decision Date2005-02-18
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K050187. 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 PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES?

PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Sofradim Production. The 510(k) number is K050187.

When did PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES receive FDA 510(k) clearance?

PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES received FDA 510(k) clearance on 2005-02-18, under 510(k) number K050187.

Who is the listed applicant for PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES?

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

What is the FDA product code for PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES?

The FDA product code for PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES is FTL.

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Other records listing Sofradim Production 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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene™ Macroporous Mesh (PPM5050 )K243315ProGrip™ Self-Gripping Polypropylene MeshK233661Transorb™ Self-Gripping Resorbable MeshK232373Progrip™ Self-Gripping Polypropylene MeshK223218Parietene Macroporous Mesh

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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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