K-number	K250904
Device name	Atalante X
Applicant	Wandercraft SAS
Product code	PHL
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	890.3480

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Atalante X

Everything you need for a 510(k) submission. Nothing you don't.