FDA 510(k) Application Details - K243503

Device Classification Name	Pump, Infusion, Ophthalmic   More FDA Info for this Device
510(K) Number	K243503
Device Name	Pump, Infusion, Ophthalmic
Applicant	New World Medical, Inc. 10763 Edison Court Rancho Cucamonga, CA 91730 US Other 510(k) Applications for this Company
Contact	Sartaj (Taj) Kaur-Hurrle Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	02/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review