SOLOS EYESITE CANNULAS— 510(k) K872610

Substantially Equivalent

Solos Ophthalmology

FDA 510(k) clearance K872610 for SOLOS EYESITE CANNULAS, Substantially Equivalent on 1987-07-31. Applicant: Solos Ophthalmology. Device class: 1.

Clearance details

Applicant
Solos Ophthalmology
Product code
Code HMX
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HMX

product code HMX
Other
1
Total
1

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.