510(k) K260945
- Device
- Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
- Applicant
- Fit-Pro KFT (Ltd.) - DBA E-Fit
- 510(k) number
- K260945
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-27
- Date received
- 2026-03-23
- Review panel
- Unknown
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Janos Papp
- Address
- Szabadság Ter. 7 Budapest HU 1054 1054