K062435
Substantially EquivalentREPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- Applicant
- Spire Biomedical, Inc.
- Product code
- NFK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.