UNITED WOUND COVERING, PACKAGE OF 5— 510(k) K863389
Substantially Equivalent for Some IndicationsUnited Medical
FDA 510(k) clearance K863389 for UNITED WOUND COVERING, PACKAGE OF 5, Substantially Equivalent for Some Indications on 1986-11-17. Applicant: United Medical.
Clearance details
- Applicant
- United Medical
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Largo, FL, US
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.