PROCLUDE— 510(k) K002989

Substantially Equivalent

Ortek Therapeutics, Inc.

FDA 510(k) clearance K002989 for PROCLUDE, Substantially Equivalent on 2000-12-14. Applicant: Ortek Therapeutics, Inc.. Device class: 1.

Clearance details

Applicant: Ortek Therapeutics, Inc.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2000-09-25
Decision date: 2000-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortek Therapeutics, Inc.

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