FDA 510(k) Application Details - K202038

Device Classification Name	Unit, Cryophthalmic   More FDA Info for this Device
510(K) Number	K202038
Device Name	Unit, Cryophthalmic
Applicant	VitreQ B.V. Segglant-Noord 2 Vierpolders 3237MG NL Other 510(k) Applications for this Company
Contact	Christian Neele Other 510(k) Applications for this Contact
Regulation Number	886.4170   More FDA Info for this Regulation Number
Classification Product Code	HPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2020
Decision Date	12/30/2020
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