CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500— 510(k) K963839
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K963839 for CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500, Substantially Equivalent on 1996-12-12. Applicant: Cordis Corp.. Device class: 1.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code GCY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4680
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
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Adverse events under product code GCY
product code GCY- Malfunction
- 786
- Other
- 1
- Total
- 787
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.