INMAN MEDICAL OIL EMULSION DRESSING— 510(k) K921290
Substantially Equivalent for Some IndicationsInman Medical Corp.
FDA 510(k) clearance K921290 for INMAN MEDICAL OIL EMULSION DRESSING, Substantially Equivalent for Some Indications on 1992-11-23. Applicant: Inman Medical Corp..
Clearance details
- Applicant
- Inman Medical Corp.
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Fort Worth, TX, 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.