EXPANDOVER ELASTIC BANDAGE— 510(k) K880207
Substantially Equivalent for Some IndicationsExpandover C/O Hale and Dorr
FDA 510(k) clearance K880207 for EXPANDOVER ELASTIC BANDAGE, Substantially Equivalent for Some Indications on 1988-04-21. Applicant: Expandover C/O Hale and Dorr.
Clearance details
- Applicant
- Expandover C/O Hale and Dorr
- Product code
- Code KGX
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Boston, MA, US
Adverse events under product code KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.