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FDA 510(k)

MODIFICATION TO REBOUND HRD

K-Number: K080393 · 2008-03-13

ApplicantMinnesota Medical Development, Inc.
Decision Date2008-03-13
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO REBOUND HRD is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Medical Development, Inc.. It received FDA 510(k) clearance on 2008-03-13 under 510(k) number K080393. 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 MODIFICATION TO REBOUND HRD?

MODIFICATION TO REBOUND HRD is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Minnesota Medical Development, Inc.. The 510(k) number is K080393.

When did MODIFICATION TO REBOUND HRD receive FDA 510(k) clearance?

MODIFICATION TO REBOUND HRD received FDA 510(k) clearance on 2008-03-13, under 510(k) number K080393.

Who is the listed applicant for MODIFICATION TO REBOUND HRD?

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

What is the FDA product code for MODIFICATION TO REBOUND HRD?

The FDA product code for MODIFICATION TO REBOUND HRD is FTL.

Related Clinical Trials

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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Other records listing Minnesota Medical Development, 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.

K083467REBOUND HRDVK063671REBOUND HRD

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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