PERFADEX SOLUTION FOR LUNG PRESERVATION— 510(k) K022730
Substantially EquivalentVitrolife AB
FDA 510(k) clearance K022730 for PERFADEX SOLUTION FOR LUNG PRESERVATION, Substantially Equivalent on 2003-10-27. Applicant: Vitrolife AB. Device class: 2.
Clearance details
- Applicant
- Vitrolife AB
- Product code
- Code MSB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringoes, NJ, US
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