CUP, DISPOSABLE MEDICINE— 510(k) K760517
Substantially EquivalentLandmark Plastics
FDA 510(k) clearance K760517 for CUP, DISPOSABLE MEDICINE, Substantially Equivalent on 1976-11-12. Applicant: Landmark Plastics.
Clearance details
- Applicant
- Landmark Plastics
- Product code
- Code KYX
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code KYX
product code KYX- Death
- 3
- Other
- 8
- Total
- 11
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.