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FDA 510(k)

MACROPORE SURGICAL BARRIER FILM

K-Number: K023643 · 2003-02-21

ApplicantMacropore Biosurgery, Inc.
Decision Date2003-02-21
Product CodeMTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MACROPORE SURGICAL BARRIER FILM is the device name listed in this FDA 510(k) record. The listed applicant is Macropore Biosurgery, Inc.. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K023643. The device is classified under product code MTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROPORE SURGICAL BARRIER FILM?

MACROPORE SURGICAL BARRIER FILM is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K023643.

When did MACROPORE SURGICAL BARRIER FILM receive FDA 510(k) clearance?

MACROPORE SURGICAL BARRIER FILM received FDA 510(k) clearance on 2003-02-21, under 510(k) number K023643.

Who is the listed applicant for MACROPORE SURGICAL BARRIER FILM?

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

What is the FDA product code for MACROPORE SURGICAL BARRIER FILM?

The FDA product code for MACROPORE SURGICAL BARRIER FILM is MTZ.

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Other records listing Macropore Biosurgery, 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.

K042261MACROPORE PURICEL LIPOPLASTY SYSTEMK041105MACROPORE HYDROSORB SPINE SYSTEMK031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETK031785MACROPORE CARDIO-WRAP (TS)K024169MACROPORE OS RECONSTRUCTIONK021164MACROPORE OS TRAUMA

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Related Devices (Code: MTZ)

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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