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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name In Situ Polymerizing Peripheral Nerve Cap
510(k) Number K252051
Device Name allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
Applicant
Tulavi Therapeutics, Inc.
160 Knowles Dr.
Lost Gatos,  CA  95032
Applicant Contact Joshua G. Vose
Correspondent
Hogan Lovells
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Janice Hogan
Classification Product Code
SBG  
Date Received07/01/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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