Cleared Special

EUSOL-C

K063617 · Al.Chi.Mi.A · Ophthalmic

Feb 2007

Decision

65d

Days

—

Risk

About This 510(k) Submission

K063617 is an FDA 510(k) clearance for the EUSOL-C, a Media, Corneal Storage, submitted by Al.Chi.Mi.A (Hasbrouck Heights, US). The FDA issued a Cleared decision on February 8, 2007, 65 days after receiving the submission on December 5, 2006. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K063617 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2006
Decision Date	February 08, 2007
Days to Decision	65 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF