MACROPORE OS RECONSTRUCTION— 510(k) K024169

Name: FDA 510(k) clearance K024169
Creator: U.S. Food and Drug Administration
Published: 2003-07-01

Substantially Equivalent

Macropore Biosurgery, Inc.

FDA 510(k) clearance K024169 for MACROPORE OS RECONSTRUCTION, Substantially Equivalent on 2003-07-01. Applicant: Macropore Biosurgery, Inc.. Device class: 2.

Clearance details

Applicant: Macropore Biosurgery, Inc.
Product code: Code EZX
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2002-12-18
Decision date: 2003-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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