510(k) K063255— D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
Substantially EquivalentSorin Group Italia S.R.L.
Clearance details
- Applicant
- Sorin Group Italia S.R.L.
- Product code
- Code DTM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.