ROEKO CALCIUM HYDROXIDE POINTS— 510(k) K973539

Substantially Equivalent

Roeko USA, Inc.

FDA 510(k) clearance K973539 for ROEKO CALCIUM HYDROXIDE POINTS, Substantially Equivalent on 1997-10-30. Applicant: Roeko USA, Inc..

Clearance details

Applicant: Roeko USA, Inc.
Product code: Code EJK
Advisory panel: Dental
Date received: 1997-09-18
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.