ARDENT NON GAMMA-2 70— 510(k) K964192

Name: FDA 510(k) clearance K964192
Creator: U.S. Food and Drug Administration
Published: 1997-01-06

Substantially Equivalent

Ardent Production Development

FDA 510(k) clearance K964192 for ARDENT NON GAMMA-2 70, Substantially Equivalent on 1997-01-06. Applicant: Ardent Production Development. Device class: 2.

Clearance details

Applicant: Ardent Production Development
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1996-10-17
Decision date: 1997-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

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