PROLONG— 510(k) DEN130047
UnknownErgon Medical , Ltd.
FDA 510(k) clearance DEN130047 for PROLONG, Unknown on 2015-03-20. Applicant: Ergon Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Ergon Medical , Ltd.
- Product code
- Code PIA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5025
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- West Sussex, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.