ROEKO SEAL— 510(k) K983037

Substantially Equivalent

Roeko Ulm, Roescheisen GmbH & Co.

FDA 510(k) clearance K983037 for ROEKO SEAL, Substantially Equivalent on 1998-10-20. Applicant: Roeko Ulm, Roescheisen GmbH & Co.. Device class: 2.

Clearance details

Applicant: Roeko Ulm, Roescheisen GmbH & Co.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1998-08-31
Decision date: 1998-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, 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.