TRIMIRA OCS 3000— 510(k) K082603

Substantially Equivalent

Remicalm, LLC

FDA 510(k) clearance K082603 for TRIMIRA OCS 3000, Substantially Equivalent on 2008-12-12. Applicant: Remicalm, LLC. Device class: 2.

Clearance details

Applicant: Remicalm, LLC
Product code: Code NXV
Device class: Class 2
Regulation: 21 CFR 872.6350
Advisory panel: Dental
Date received: 2008-09-08
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.