PROTEMP II— 510(k) K900436

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K900436 for PROTEMP II, Substantially Equivalent on 1990-03-28. Applicant: Espe GmbH (Us). Device class: 2.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1990-01-30
Decision date: 1990-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

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K913965 — ESPE(R) -SIL1991-12-04

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