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FDA 510(k)

SEPRAMESH, MODEL 5959-1214

K-Number: K063739 · 2007-01-17

ApplicantGenzyme Corporation
Decision Date2007-01-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEPRAMESH, MODEL 5959-1214 is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K063739. 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, MODEL 5959-1214?

SEPRAMESH, MODEL 5959-1214 is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is Genzyme Corporation. The 510(k) number is K063739.

When did SEPRAMESH, MODEL 5959-1214 receive FDA 510(k) clearance?

SEPRAMESH, MODEL 5959-1214 received FDA 510(k) clearance on 2007-01-17, under 510(k) number K063739.

Who is the listed applicant for SEPRAMESH, MODEL 5959-1214?

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, MODEL 5959-1214?

The FDA product code for SEPRAMESH, MODEL 5959-1214 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.

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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.

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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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