IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES— 510(k) K861545
Substantially EquivalentRophae Lens Co., Inc.
FDA 510(k) clearance K861545 for IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES, Substantially Equivalent on 1986-05-28. Applicant: Rophae Lens Co., Inc..
Clearance details
- Applicant
- Rophae Lens Co., Inc.
- Product code
- Code HMX
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
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.