FDA 510(k) Application Details - K243322

Device Classification Name	More FDA Info for this Device
510(K) Number	K243322
Device Name	Altaviz Intravitreal Syringe
Applicant	Altaviz, LLC 13766 Alton Parkway, Suite 143 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	James Lescoulie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2024
Decision Date	05/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review