JAMBRO Single Core A Sterilization wrap— 510(k) K182656
Substantially EquivalentJiangsu Zhande Medical Supplies Co., Ltd.
FDA 510(k) clearance K182656 for JAMBRO Single Core A Sterilization wrap, Substantially Equivalent on 2019-06-11. Applicant: Jiangsu Zhande Medical Supplies Co., Ltd..
Clearance details
- Applicant
- Jiangsu Zhande Medical Supplies Co., Ltd.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.