SOWELL COBALT-CHROME METAL ALLOY— 510(k) K973567

Name: FDA 510(k) clearance K973567
Creator: U.S. Food and Drug Administration
Published: 1997-12-11

Substantially Equivalent

C.K. International Trading

FDA 510(k) clearance K973567 for SOWELL COBALT-CHROME METAL ALLOY, Substantially Equivalent on 1997-12-11. Applicant: C.K. International Trading. Device class: 2.

Clearance details

Applicant: C.K. International Trading
Product code: Code EJH
Device class: Class 2
Regulation: 21 CFR 872.3710
Advisory panel: Dental
Date received: 1997-09-19
Decision date: 1997-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arcadia, CA, 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.