VIVALLOY HR— 510(k) K982458

Substantially Equivalent

Ab Ardent

FDA 510(k) clearance K982458 for VIVALLOY HR, Substantially Equivalent on 1998-08-24. 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: 1998-07-15
Decision date: 1998-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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