FUTURA TOPCAP NON GAMMA-2— 510(k) K011801

Substantially Equivalent

Ab Ardent

FDA 510(k) clearance K011801 for FUTURA TOPCAP NON GAMMA-2, Substantially Equivalent on 2001-08-16. Applicant: Ab Ardent. Device class: 2.

Clearance details

Applicant: Ab Ardent
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 2001-06-08
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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