FDA 510(k) Application Details - K170629

Device Classification Name	More FDA Info for this Device
510(K) Number	K170629
Device Name	VITRUVIAN INFILTRATION PUMP
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	03/02/2017
Decision Date	06/22/2017
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