DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404— 510(k) K101276
Substantially EquivalentChemence Medical Products, Inc.
FDA 510(k) clearance K101276 for DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404, Substantially Equivalent on 2010-07-28. Applicant: Chemence Medical Products, Inc..
Clearance details
- Applicant
- Chemence Medical Products, Inc.
- Product code
- Code MPN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Adverse events under product code MPN
product code MPN- Injury
- 856
- Other
- 1
- Total
- 857
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.