OSTIM— 510(k) K030052

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K030052 for OSTIM, Substantially Equivalent on 2004-12-06. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2003-01-06
Decision date: 2004-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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