PROCLUDE-SENSITIVE— 510(k) K003482

Substantially Equivalent

Ortek Therapeutics, Inc.

FDA 510(k) clearance K003482 for PROCLUDE-SENSITIVE, Substantially Equivalent on 2001-02-01. Applicant: Ortek Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Ortek Therapeutics, Inc.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2000-11-09
Decision date: 2001-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.