Name: Predicase
Price: 199 USD

K-number	K252051
Device name	allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
Applicant	Tulavi Therapeutics, Inc.
Product code	SBG
Device class	Class II
Decision date	Sep 29, 2025
Decision	Substantially Equivalent
Regulation	—

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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allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

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