TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX— 510(k) K901845
Substantially Equivalent for Some Indications3M Company
FDA 510(k) clearance K901845 for TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX, Substantially Equivalent for Some Indications on 1990-07-23. Applicant: 3M Company. Device class: 1.
Clearance details
- Applicant
- 3M Company
- Product code
- Code KGX
- Device class
- Class 1
- Regulation
- 21 CFR 880.5240
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Cottae Grove, MN, US
Recent devices under product code KGX
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- 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 KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.