K260945Substantially Equivalent

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)

Name: K260945 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)
Creator: Fit-Pro KFT (Ltd.) - DBA E-Fit
Published: 2026-09-27
License: https://open.fda.gov/license/

Fit-Pro KFT (Ltd.) - DBA E-Fit, Budapest, HU / Traditional, Substantially Equivalent

FDA source 510(k) summary

Clearance record

Decision date: 2026-09-27
Received: 2026-03-23 (188 days to decision)
Review panel: Unknown
Applicant: Fit-Pro KFT (Ltd.) - DBA E-Fit Szabadság Ter. 7, Budapest, HU
510(k) summary: Summary PDF
Third party review: No