Cleared Special

CENTURION SES EPIKERATOME

K042810 · Norwood Abbey , Ltd. · Ophthalmic

Oct 2004

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K042810 is an FDA 510(k) clearance for the 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 October 28, 2004, 16 days after receiving the submission on October 12, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K042810 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 2004
Decision Date	October 28, 2004
Days to Decision	16 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF