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FDA 510(k)

ATRIUM PROLITE S MESH

K-Number: K082748 · 2009-01-14

ApplicantAtrium Medical Corp.
Decision Date2009-01-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUM PROLITE S MESH is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2009-01-14 under 510(k) number K082748. 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 ATRIUM PROLITE S MESH?

ATRIUM PROLITE S MESH is a medical device that received FDA 510(k) clearance on 2009-01-14. The listed applicant is Atrium Medical Corp.. The 510(k) number is K082748.

When did ATRIUM PROLITE S MESH receive FDA 510(k) clearance?

ATRIUM PROLITE S MESH received FDA 510(k) clearance on 2009-01-14, under 510(k) number K082748.

Who is the listed applicant for ATRIUM PROLITE S MESH?

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

What is the FDA product code for ATRIUM PROLITE S MESH?

The FDA product code for ATRIUM PROLITE S MESH is FTL.

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Other records listing Atrium Medical Corp. 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.

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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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