GLUMA ONE BOND— 510(k) K974390

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K974390 for GLUMA ONE BOND, Substantially Equivalent on 1998-02-04. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1997-11-21
Decision date: 1998-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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