Aqueduct 100 Plus Cervical Dilation Balloon Catheter— 510(k) K202427
Substantially EquivalentGtimd, LLC
FDA 510(k) clearance K202427 for Aqueduct 100 Plus Cervical Dilation Balloon Catheter, Substantially Equivalent on 2020-11-06. Applicant: Gtimd, LLC.
Clearance details
- Applicant
- Gtimd, LLC
- Product code
- Code PON
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Amherst, NH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.