CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR— 510(k) K073060

Substantially Equivalent

Innova Vision, Inc.

FDA 510(k) clearance K073060 for CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 2007-11-29. Applicant: Innova Vision, Inc.. Device class: 2.

Clearance details

Applicant
Innova Vision, Inc.
Product code
Code MVN
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Flagstaff, AZ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MVN

product code MVN
Injury
149
Total
149

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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