PROLONG
FDA 510(k) clearance DEN130047 · decided 2015-03-20
Clearance details
- K-number
- DEN130047
- Device name
- PROLONG
- Applicant
- Ergon Medical , Ltd.
- Decision
- Unknown
- Date received
- 2013-11-18
- Decision date
- 2015-03-20
- Days to decision
- 487 days
- Clearance type
- Direct
- Product code
- PIA
- Device class
- 2
- Regulation number
- 876.5025
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- West Sussex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.