TEGASORB(TM) ULCER DRESSING, #90-XXX— 510(k) K891288
Substantially Equivalent for Some Indications3M Company
FDA 510(k) clearance K891288 for TEGASORB(TM) ULCER DRESSING, #90-XXX, Substantially Equivalent for Some Indications on 1989-06-09. Applicant: 3M Company. Device class: Unclassified.
Clearance details
- Applicant
- 3M Company
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Cottae Grove, MN, US
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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.