FDA 510(k) Application Details - K161722

Device Classification Name	More FDA Info for this Device
510(K) Number	K161722
Device Name	VITRUVIAN ULTIMATE ASPIRATOR
Applicant	BLACK & BLACK SURGICAL, INC. 5238 ROYAL WOODS PKWY, SUITE 170 TUCKER, GA 30084 US Other 510(k) Applications for this Company
Contact	CYNTHIA REES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2016
Decision Date	07/26/2016
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	Y
Expedited Review