STORZ DRAEGER ROTOR KERATOME— 510(k) K904845
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K904845 for STORZ DRAEGER ROTOR KERATOME, Substantially Equivalent on 1991-01-22. Applicant: Storz Instrument Co.. Device class: 1.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code HNO
- Device class
- Class 1
- Regulation
- 21 CFR 886.4370
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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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.