COCOON HYGIENIST— 510(k) K040529

Substantially Equivalent

Satelec

FDA 510(k) clearance K040529 for COCOON HYGIENIST, Substantially Equivalent on 2004-08-19. Applicant: Satelec. Device class: 1.

Clearance details

Applicant: Satelec
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2004-03-01
Decision date: 2004-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, 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.