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FDA 510(k)

BIOMESH P1 AND BIOMESH PLUG AND PATCH

K-Number: K002479 · 2000-10-19

ApplicantCousin Biotech S.A.R.L
Decision Date2000-10-19
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMESH P1 AND BIOMESH PLUG AND PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Cousin Biotech S.A.R.L. It received FDA 510(k) clearance on 2000-10-19 under 510(k) number K002479. 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 BIOMESH P1 AND BIOMESH PLUG AND PATCH?

BIOMESH P1 AND BIOMESH PLUG AND PATCH is a medical device that received FDA 510(k) clearance on 2000-10-19. The listed applicant is Cousin Biotech S.A.R.L. The 510(k) number is K002479.

When did BIOMESH P1 AND BIOMESH PLUG AND PATCH receive FDA 510(k) clearance?

BIOMESH P1 AND BIOMESH PLUG AND PATCH received FDA 510(k) clearance on 2000-10-19, under 510(k) number K002479.

Who is the listed applicant for BIOMESH P1 AND BIOMESH PLUG AND PATCH?

The FDA 510(k) record lists Cousin Biotech S.A.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMESH P1 AND BIOMESH PLUG AND PATCH?

The FDA product code for BIOMESH P1 AND BIOMESH PLUG AND PATCH is FTL.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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