FDA 510(k) Application Details - K223183

Device Classification Name	Illuminator, Fiberoptic, Surgical Field   More FDA Info for this Device
510(K) Number	K223183
Device Name	Illuminator, Fiberoptic, Surgical Field
Applicant	Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg 22045 DE Other 510(k) Applications for this Company
Contact	Ali Sayad Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	HBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2022
Decision Date	01/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review