OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.— 510(k) K070628

Name: FDA 510(k) clearance K070628
Creator: U.S. Food and Drug Administration
Published: 2007-05-01

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K070628 for OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS., Substantially Equivalent on 2007-05-01. Applicant: Contamac, Ltd.. Device class: 2.

Clearance details

Applicant: Contamac, Ltd.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2007-03-07
Decision date: 2007-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.