ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)— 510(k) K013756

Name: FDA 510(k) clearance K013756
Creator: U.S. Food and Drug Administration
Published: 2002-08-29

Substantially Equivalent

Argus Biomedical Pty, Ltd.

FDA 510(k) clearance K013756 for ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES), Substantially Equivalent on 2002-08-29. Applicant: Argus Biomedical Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Argus Biomedical Pty, Ltd.
Product code: Code HQM
Device class: Class 2
Regulation: 21 CFR 886.3400
Advisory panel: Ophthalmic
Date received: 2001-11-13
Decision date: 2002-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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