Cleared Traditional

K032422 - EUSOL-C
(FDA 510(k) Clearance)

K032422 · Al.Chi.Mi.A · Ophthalmic

Dec 2003

Decision

132d

Days

—

Risk

K032422 is an FDA 510(k) clearance for the EUSOL-C. This device is classified as a Media, Corneal Storage.

Submitted by Al.Chi.Mi.A (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 15, 2003, 132 days after receiving the submission on August 5, 2003.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K032422 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 05, 2003
Decision Date	December 15, 2003
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF