Cleared Traditional

CORDCAP

K091380 · Centrix, Inc. · Dental
Jul 2009
Decision
80d
Days
—
Risk

About This 510(k) Submission

K091380 is an FDA 510(k) clearance for the CORDCAP, a Cord, Retraction, submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 30, 2009, 80 days after receiving the submission on May 11, 2009. This device falls under the Dental review panel.

Submission Details

510(k) Number K091380 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2009
Decision Date July 30, 2009
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL — Cord, Retraction
Device Class —