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FDA 510(k)

SURGI-WRAP MAST TENDON SHEET

K-Number: K063648 · 2007-03-07

ApplicantMast Biosurgery USA, Inc.
Decision Date2007-03-07
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGI-WRAP MAST TENDON SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Mast Biosurgery USA, Inc.. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K063648. 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 SURGI-WRAP MAST TENDON SHEET?

SURGI-WRAP MAST TENDON SHEET is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Mast Biosurgery USA, Inc.. The 510(k) number is K063648.

When did SURGI-WRAP MAST TENDON SHEET receive FDA 510(k) clearance?

SURGI-WRAP MAST TENDON SHEET received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063648.

Who is the listed applicant for SURGI-WRAP MAST TENDON SHEET?

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

What is the FDA product code for SURGI-WRAP MAST TENDON SHEET?

The FDA product code for SURGI-WRAP MAST TENDON SHEET 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 Mast Biosurgery USA, 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.

K090637CARDIO-WRAPK061473SURGI-WRAP MAST BIORESORBABLE SHEETK050332SURGI-WRAP MAST BIORESORBABLE SHEET

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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