Cleared Traditional

EMBOZENE MICROSPHERES

K073417 · Celonova Biosciences, Inc. · Cardiovascular
Dec 2008
Decision
377d
Days
Class 2
Risk

About This 510(k) Submission

K073417 is an FDA 510(k) clearance for the EMBOZENE MICROSPHERES, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Celonova Biosciences, Inc. (Newnan, US). The FDA issued a Cleared decision on December 15, 2008, 377 days after receiving the submission on December 4, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K073417 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2007
Decision Date December 15, 2008
Days to Decision 377 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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