FDA 510(k) Application Details - K202694

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K202694
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	Vycor Medical INC. 951 Broken Sound Parkway, STE 320 Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Theo Novak Other 510(k) Applications for this Contact
Regulation Number	882.4800   More FDA Info for this Regulation Number
Classification Product Code	GZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2020
Decision Date	01/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review