IBOND GLUMA INSIDE— 510(k) K022612

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K022612 for IBOND GLUMA INSIDE, Substantially Equivalent on 2002-10-28. 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: 2002-08-06
Decision date: 2002-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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