510(k) K231804
- Device
- PRIME-XV FreezIS DMSO-Free MD
- Applicant
- Fujifilm Irvine Scientific
- 510(k) number
- K231804
- Product code
- NDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-09
- Date received
- 2023-06-20
- Regulation
- 876.5885
- Classification name
- Media, Culture, Ex Vivo, Tissue And Cell
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Amanda Cinquin
- Address
- 1830 E. Warner Ave. Santa Ana CA US 92705 92705
FDA Registration Numbers
- 3016633010
Source Documents
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