SUNTOUCH TOPICAL HEMOSTATIC DRESSING— 510(k) K112800
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K112800 for SUNTOUCH TOPICAL HEMOSTATIC DRESSING, Substantially Equivalent on 2012-05-23. Applicant: Huizhou Foryou Medical Devices Co., Ltd..
Clearance details
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Product code
- Code QSY
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pennington, NJ, US
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.