PROSTYLE COMPACT— 510(k) K961420

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K961420 for PROSTYLE COMPACT, Substantially Equivalent on 1996-09-10. Applicant: Planmeca Oy. Device class: 1.

Clearance details

Applicant: Planmeca Oy
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1996-04-12
Decision date: 1996-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.