FDA 510(k) Application Details - K203229

Device Classification Name	Sizer, Mammary, Breast Implant Volume   More FDA Info for this Device
510(K) Number	K203229
Device Name	Sizer, Mammary, Breast Implant Volume
Applicant	Allergan 2525 Dupont Dr. Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Kelly Carty 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	11/02/2020
Decision Date	06/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review