FDA 510(k) Application Details - K220030

Device Classification Name	Vitrectomy, Instrument Cutter   More FDA Info for this Device
510(K) Number	K220030
Device Name	Vitrectomy, Instrument Cutter
Applicant	Vista Ophthalmics LLC 23510 Kingsland Blvd. Suite 200 Katy, TX 77494 US Other 510(k) Applications for this Company
Contact	Don Knowles Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	MLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2022
Decision Date	05/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review