ISOSTATIC CONDENSER— 510(k) K843901

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K843901 for ISOSTATIC CONDENSER, Substantially Equivalent on 1984-12-03. Applicant: Shofu Dental Corp.. Device class: 1.

Clearance details

Applicant: Shofu Dental Corp.
Product code: Code EKG
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1984-10-03
Decision date: 1984-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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