THERAFORM BILAYER— 510(k) K090823
Substantially EquivalentSewon Cellontech Co., Ltd.
FDA 510(k) clearance K090823 for THERAFORM BILAYER, Substantially Equivalent on 2009-10-22. Applicant: Sewon Cellontech Co., Ltd..
Clearance details
- Applicant
- Sewon Cellontech Co., Ltd.
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Fe Springs, CA, 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.