Cleared Abbreviated

MORPHEUS

K082249 · Meibach Tech Ltda · Dental
Dec 2009
Decision
510d
Days
Class 2
Risk

About This 510(k) Submission

K082249 is an FDA 510(k) clearance for the MORPHEUS, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Meibach Tech Ltda (New York, US). The FDA issued a Cleared decision on December 31, 2009, 510 days after receiving the submission on August 8, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number K082249 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2008
Decision Date December 31, 2009
Days to Decision 510 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJI — Syringe, Cartridge
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6770

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