FDA 510(k) Application Details - K183163

Device Classification Name	Sizer, Mammary, Breast Implant Volume   More FDA Info for this Device
510(K) Number	K183163
Device Name	Sizer, Mammary, Breast Implant Volume
Applicant	Motiva USA, LLC 712 Fifth Avenue 14th Floor New York, NY 10019-4108 US Other 510(k) Applications for this Company
Contact	ALberto Quesada Rivera Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2018
Decision Date	02/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review