CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3— 510(k) K030682

Name: FDA 510(k) clearance K030682
Creator: U.S. Food and Drug Administration
Published: 2003-06-27

Substantially Equivalent

Bioform, Inc.

FDA 510(k) clearance K030682 for CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3, Substantially Equivalent on 2003-06-27. Applicant: Bioform, Inc.. Device class: 2.

Clearance details

Applicant: Bioform, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2003-03-05
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franksville, WI, US

Download summary PDF View on FDA.gov ↗

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