OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES— 510(k) K081178
Substantially EquivalentContamac, Ltd.
FDA 510(k) clearance K081178 for OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES, Substantially Equivalent on 2008-10-09. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Junction, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.