ERB ENDORECTAL BALLOON— 510(k) K141958
Substantially EquivalentEdge Medical, LLC
FDA 510(k) clearance K141958 for ERB ENDORECTAL BALLOON, Substantially Equivalent on 2014-11-18. Applicant: Edge Medical, LLC.
Clearance details
- Applicant
- Edge Medical, LLC
- Product code
- Code PCT
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lutsen, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.