AUTOGENESIS AUTOMATOR, MODEL M1000— 510(k) K013818

Name: FDA 510(k) clearance K013818
Creator: U.S. Food and Drug Administration
Published: 2001-12-05

Substantially Equivalent

Autogenesis, Inc.

FDA 510(k) clearance K013818 for AUTOGENESIS AUTOMATOR, MODEL M1000, Substantially Equivalent on 2001-12-05. Applicant: Autogenesis, Inc.. Device class: 2.

Clearance details

Applicant: Autogenesis, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-11-16
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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