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FDA 510(k)

3D ANATOMICAL MESH

K-Number: K990930 · 1999-06-17

ApplicantSanterra Medical Technology, Inc.
Decision Date1999-06-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3D ANATOMICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Santerra Medical Technology, Inc.. It received FDA 510(k) clearance on 1999-06-17 under 510(k) number K990930. 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 3D ANATOMICAL MESH?

3D ANATOMICAL MESH is a medical device that received FDA 510(k) clearance on 1999-06-17. The listed applicant is Santerra Medical Technology, Inc.. The 510(k) number is K990930.

When did 3D ANATOMICAL MESH receive FDA 510(k) clearance?

3D ANATOMICAL MESH received FDA 510(k) clearance on 1999-06-17, under 510(k) number K990930.

Who is the listed applicant for 3D ANATOMICAL MESH?

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

What is the FDA product code for 3D ANATOMICAL MESH?

The FDA product code for 3D ANATOMICAL MESH 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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