510(k) K970266— KENDALL HYDROPHILIC POWDER WOUND DRESSING
Substantially Equivalent for Some IndicationsKendall Healthcare Products Co. Div.Of Tyco Health
Clearance details
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.