PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES— 510(k) K953959
Substantially EquivalentMicrosurgical Technology, Inc.
FDA 510(k) clearance K953959 for PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES, Substantially Equivalent on 1995-11-17. Applicant: Microsurgical Technology, Inc..
Clearance details
- Applicant
- Microsurgical Technology, Inc.
- Product code
- Code HQC
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.