ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)— 510(k) K972883
Substantially EquivalentCypress Medical Products, Ltd.
FDA 510(k) clearance K972883 for ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW), Substantially Equivalent on 1998-02-26. Applicant: Cypress Medical Products, Ltd..
Clearance details
- Applicant
- Cypress Medical Products, Ltd.
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mc Henry, IL, US
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.