SUMMA DISK— 510(k) K833038

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K833038 for SUMMA DISK, Substantially Equivalent on 1983-10-04. Applicant: Shofu Dental Corp.. Device class: 1.

Clearance details

Applicant: Shofu Dental Corp.
Product code: Code DZP
Device class: Class 1
Regulation: 21 CFR 872.4535
Advisory panel: Dental
Date received: 1983-09-06
Decision date: 1983-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.