TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX— 510(k) K901845

Substantially Equivalent for Some Indications

3M 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.

Clearance details

Applicant
3M Company
Product code
Code KGX
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Cottae Grove, MN, US
Download summary PDFView on FDA.gov ↗

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.