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FDA 510(k)

SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX

K-Number: K994328 · 2000-03-02

ApplicantGenzyme Corp.
Decision Date2000-03-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2000-03-02 under 510(k) number K994328. 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 BIOSURGICAL COMPOSITE, MODEL SMBC-XXX?

SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX is a medical device that received FDA 510(k) clearance on 2000-03-02. The listed applicant is Genzyme Corp.. The 510(k) number is K994328.

When did SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX receive FDA 510(k) clearance?

SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX received FDA 510(k) clearance on 2000-03-02, under 510(k) number K994328.

Who is the listed applicant for SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX?

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 BIOSURGICAL COMPOSITE, MODEL SMBC-XXX?

The FDA product code for SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX is FTL.

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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

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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