GLENROE GLOW IN DARK ELASTOMERIC LIGATURES— 510(k) K973495

Name: FDA 510(k) clearance K973495
Creator: U.S. Food and Drug Administration
Published: 1997-12-01

Substantially Equivalent

Glenroe

FDA 510(k) clearance K973495 for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES, Substantially Equivalent on 1997-12-01. Applicant: Glenroe. Device class: 1.

Clearance details

Applicant: Glenroe
Product code: Code ECI
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1997-09-16
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, US

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