SULCUS BLUE— 510(k) K111978

Name: FDA 510(k) clearance K111978
Creator: U.S. Food and Drug Administration
Published: 2011-10-13

Substantially Equivalent

Produits Dentaires Pierre Rolland

FDA 510(k) clearance K111978 for SULCUS BLUE, Substantially Equivalent on 2011-10-13. Applicant: Produits Dentaires Pierre Rolland. Device class: Unclassified.

Clearance details

Applicant: Produits Dentaires Pierre Rolland
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-07-12
Decision date: 2011-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

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