K912451
Substantially EquivalentURODYNAMIC RECTAL BALLOON
- Applicant
- Cook Urological, Inc.
- Product code
- FAP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.