OSTEOGEN SBRG— 510(k) K033098

Substantially Equivalent

Impladent , Ltd.

FDA 510(k) clearance K033098 for OSTEOGEN SBRG, Substantially Equivalent on 2004-04-27. Applicant: Impladent , Ltd.. Device class: 2.

Clearance details

Applicant: Impladent , Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2003-09-29
Decision date: 2004-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollis, NY, US

Download summary PDF View on FDA.gov ↗

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