CARRIAZO-PENDULAR MICROKERATOME— 510(k) K082043
Substantially EquivalentSchwind Eye-Tech-Solutions GmbH & Co. KG
FDA 510(k) clearance K082043 for CARRIAZO-PENDULAR MICROKERATOME, Substantially Equivalent on 2008-08-01. Applicant: Schwind Eye-Tech-Solutions GmbH & Co. KG.
Clearance details
- Applicant
- Schwind Eye-Tech-Solutions GmbH & Co. KG
- Product code
- Code HNO
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kleinostheim, DE
Adverse events under product code HNO
product code HNO- Injury
- 390
- Total
- 390
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.