3M TEGADERM CHG DRESSING— 510(k) K063458
Substantially Equivalent3M Company
FDA 510(k) clearance K063458 for 3M TEGADERM CHG DRESSING, Substantially Equivalent on 2007-04-05. 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
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FRO
view allMore clearances from 3M Company
view all- K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE +3 more
- K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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 →
Recalls naming K063458
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 K063458.
Data sourced from openFDA. This site is unofficial and independent of the FDA.