FDA 510(k) Application Details - K233653

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K233653
Device Name	Endoilluminator
Applicant	Peregrine Surgical, LLC 51 Britain Drive New Britain, PA 18901 US Other 510(k) Applications for this Company
Contact	Melissa DeHass Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2023
Decision Date	08/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review