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FDA 510(k)

PARIETEX PLUG AND PATCH

K-Number: K101519 · 2010-11-05

ApplicantSofradim Production
Decision Date2010-11-05
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARIETEX PLUG AND PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2010-11-05 under 510(k) number K101519. 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 PLUG AND PATCH?

PARIETEX PLUG AND PATCH is a medical device that received FDA 510(k) clearance on 2010-11-05. The listed applicant is Sofradim Production. The 510(k) number is K101519.

When did PARIETEX PLUG AND PATCH receive FDA 510(k) clearance?

PARIETEX PLUG AND PATCH received FDA 510(k) clearance on 2010-11-05, under 510(k) number K101519.

Who is the listed applicant for PARIETEX PLUG AND PATCH?

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 PLUG AND PATCH?

The FDA product code for PARIETEX PLUG AND PATCH 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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