PERFADEX SOLUTION FOR ORGAN PRESERVATION— 510(k) K000881
Substantially EquivalentVitrolife Sweden AB
FDA 510(k) clearance K000881 for PERFADEX SOLUTION FOR ORGAN PRESERVATION, Substantially Equivalent on 2001-03-08. Applicant: Vitrolife Sweden AB. Device class: 2.
Clearance details
- Applicant
- Vitrolife Sweden 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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