EXPANDOVER ELASTIC BANDAGE— 510(k) K880207

Substantially Equivalent for Some Indications

Expandover 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
Download summary PDFView on FDA.gov ↗

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.