MITRASHEER TRANSPLANT DRESSING— 510(k) K911649
Substantially EquivalentPolymint Industrial Co. , Ltd.
FDA 510(k) clearance K911649 for MITRASHEER TRANSPLANT DRESSING, Substantially Equivalent on 1991-08-07. Applicant: Polymint Industrial Co. , Ltd..
Clearance details
- Applicant
- Polymint Industrial Co. , Ltd.
- Product code
- Code MGP
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
Adverse events under product code MGP
product code MGP- Other
- 1
- Total
- 1
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.