510(k) K070048— GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
Substantially EquivalentMarian Medical, Inc.
Clearance details
- Applicant
- Marian Medical, Inc.
- Product code
- Code FCM
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.