Cleared Traditional

Cornea Cold

K151061 · Eurobio · Ophthalmic

Aug 2015

Decision

108d

Days

—

Risk

About This 510(k) Submission

K151061 is an FDA 510(k) clearance for the Cornea Cold, a Media, Corneal Storage, submitted by Eurobio (Les Ulis, FR). The FDA issued a Cleared decision on August 6, 2015, 108 days after receiving the submission on April 20, 2015. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K151061 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2015
Decision Date	August 06, 2015
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF