MODIFICATION TO 3M TEGADERM CHG DRESSING— 510(k) K080620
Substantially Equivalent3M Company-3M Health Care
FDA 510(k) clearance K080620 for MODIFICATION TO 3M TEGADERM CHG DRESSING, Substantially Equivalent on 2008-05-19. Applicant: 3M Company-3M Health Care. Device class: Unclassified.
Clearance details
- Applicant
- 3M Company-3M Health Care
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code FRO
view allMore clearances from 3M Company-3M Health Care
view allAdverse 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 →
Recalls naming K080620
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080620.
Data sourced from openFDA. This site is unofficial and independent of the FDA.