MONARCH II BLEACHING INSTRUMENT— 510(k) K854692

Name: FDA 510(k) clearance K854692
Creator: U.S. Food and Drug Administration
Published: 1986-05-12

Substantially Equivalent

Almore Intl., Inc.

FDA 510(k) clearance K854692 for MONARCH II BLEACHING INSTRUMENT, Substantially Equivalent on 1986-05-12. Applicant: Almore Intl., Inc.. Device class: 1.

Clearance details

Applicant: Almore Intl., Inc.
Product code: Code EEG
Device class: Class 1
Regulation: 21 CFR 872.6475
Advisory panel: Dental
Date received: 1985-11-21
Decision date: 1986-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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