UNIVERSAL BONE CEMENT KIT— 510(k) K931540

Name: FDA 510(k) clearance K931540
Creator: U.S. Food and Drug Administration
Published: 1994-01-27

Substantially Equivalent

Biodynamic Technologies, Inc.

FDA 510(k) clearance K931540 for UNIVERSAL BONE CEMENT KIT, Substantially Equivalent on 1994-01-27. Applicant: Biodynamic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1993-03-29
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

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