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FDA 510(k)

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205

K-Number: K003323 · 2001-01-22

ApplicantDavol, Inc.
Decision Date2001-01-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K003323. 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 COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205?

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Davol, Inc.. The 510(k) number is K003323.

When did COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 receive FDA 510(k) clearance?

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 received FDA 510(k) clearance on 2001-01-22, under 510(k) number K003323.

Who is the listed applicant for COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205?

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

What is the FDA product code for COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205?

The FDA product code for COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 is FTL.

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Other records listing Davol, Inc. 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005K931899DAVOL ATS

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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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