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FDA 510(k)

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

K-Number: K040868 · 2004-06-04

ApplicantGenzyme Corp.
Decision Date2004-06-04
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040868. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH?

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Genzyme Corp.. The 510(k) number is K040868.

When did SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH receive FDA 510(k) clearance?

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040868.

Who is the listed applicant for SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH?

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

What is the FDA product code for SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH?

The FDA product code for SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH is FTM.

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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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