COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC— 510(k) K900105
Substantially EquivalentCobe Laboratories, Inc.
FDA 510(k) clearance K900105 for COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC, Substantially Equivalent on 1991-03-22. Applicant: Cobe Laboratories, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Cobe Laboratories, Inc.
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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More clearances from Cobe Laboratories, Inc.
view allAdverse events under product code LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 364
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.