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FDA 510(k)

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

K-Number: K053066 · 2005-12-19

ApplicantGenzyme Corporation
Decision Date2005-12-19
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2005-12-19 under 510(k) number K053066. 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 SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH?

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH is a medical device that received FDA 510(k) clearance on 2005-12-19. The listed applicant is Genzyme Corporation. The 510(k) number is K053066.

When did SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH receive FDA 510(k) clearance?

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH received FDA 510(k) clearance on 2005-12-19, under 510(k) number K053066.

Who is the listed applicant for SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH?

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

What is the FDA product code for SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH?

The FDA product code for SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH is FTL.

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Other records listing Genzyme Corporation 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.

K102242OSOM C. DIFFICILE TOXIN A/B TESTK092633OSOM INFLUENZA A&B TEST , MODEL PN190K080662GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORK063739SEPRAMESH, MODEL 5959-1214K043035SEPRAGEL ENT BIORESORBABLE PACKING/STENT

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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