IMPERVA ENSURABOND— 510(k) K953613

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K953613 for IMPERVA ENSURABOND, Substantially Equivalent on 1995-10-04. Applicant: Shofu Dental Corp.. Device class: 2.

Clearance details

Applicant: Shofu Dental Corp.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1995-08-02
Decision date: 1995-10-04
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.