Cleared Special

NORWOOD ABBEY CENTURION SES EPIKERATOME

K051486 · Norwood Abbey , Ltd. · Ophthalmic

Jul 2005

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K051486 is an FDA 510(k) clearance for the NORWOOD ABBEY CENTURION SES EPIKERATOME, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Norwood Abbey , Ltd. (Chelsea Hgts., Victoria, AU). The FDA issued a Cleared decision on July 6, 2005, 30 days after receiving the submission on June 6, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K051486 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2005
Decision Date	July 06, 2005
Days to Decision	30 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF