Cleared Traditional

LIFE4C

K063304 · Numedis, Inc. · Ophthalmic

Dec 2007

Decision

415d

Days

—

Risk

About This 510(k) Submission

K063304 is an FDA 510(k) clearance for the LIFE4C, a Media, Corneal Storage, submitted by Numedis, Inc. (Monson, US). The FDA issued a Cleared decision on December 21, 2007, 415 days after receiving the submission on November 1, 2006. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K063304 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2006
Decision Date	December 21, 2007
Days to Decision	415 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF