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FDA 510(k)

Parietene DS Composite Mesh

K-Number: K163212 · 2017-06-29

ApplicantSofradim Production
Decision Date2017-06-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Parietene DS Composite Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K163212. 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 Parietene DS Composite Mesh?

Parietene DS Composite Mesh is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Sofradim Production. The 510(k) number is K163212.

When did Parietene DS Composite Mesh receive FDA 510(k) clearance?

Parietene DS Composite Mesh received FDA 510(k) clearance on 2017-06-29, under 510(k) number K163212.

Who is the listed applicant for Parietene DS Composite Mesh?

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 Parietene DS Composite Mesh?

The FDA product code for Parietene DS Composite Mesh is FTL.

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

View all 11 devices →

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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