3I CALCIUM SULFATE BONE CEMENT— 510(k) K012047

Name: FDA 510(k) clearance K012047
Creator: U.S. Food and Drug Administration
Published: 2001-09-19

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K012047 for 3I CALCIUM SULFATE BONE CEMENT, Substantially Equivalent on 2001-09-19. Applicant: Implant Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2001-06-29
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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