AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000— 510(k) K981423

Name: FDA 510(k) clearance K981423
Creator: U.S. Food and Drug Administration
Published: 1998-05-20

Substantially Equivalent

Autogenesis, Inc.

FDA 510(k) clearance K981423 for AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000, Substantially Equivalent on 1998-05-20. 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: 1998-04-20
Decision date: 1998-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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