SOLIDEX— 510(k) K972292

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K972292 for SOLIDEX, Substantially Equivalent on 1997-10-29. Applicant: Shofu Dental Corp.. Device class: 2.

Clearance details

Applicant: Shofu Dental Corp.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1997-06-19
Decision date: 1997-10-29
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.