Cleared Traditional

K051414 - EYE CUP, STERILE 1 AND NON STERILE
(FDA 510(k) Clearance)

K051414 · Tollot Pty.Ltd.(Aaxis Pacific) · Ophthalmic device

Jun 2005

Decision

16d

Days

—

Risk

K051414 is an FDA 510(k) clearance for the EYE CUP, STERILE 1 AND NON STERILE. This device is classified as a Cup, Eye.

Submitted by Tollot Pty.Ltd.(Aaxis Pacific) (Littleton, US). The FDA issued a Cleared decision on June 16, 2005, 16 days after receiving the submission on May 31, 2005.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K051414 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 2005
Decision Date	June 16, 2005
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement