COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS— 510(k) K872214
Substantially EquivalentCooperVision, Inc.
FDA 510(k) clearance K872214 for COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS, Substantially Equivalent on 1987-08-17. Applicant: CooperVision, Inc.. Device class: 1.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code GEA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code GEA
product code GEA- Malfunction
- 587
- Total
- 587
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.