FDA 510(k) Application Details - K221127

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K221127
Device Name	Expander, Skin, Inflatable
Applicant	Sientra, Inc. 420 South Fairview Avenue Suite 200 Santa Barbara, CA 93117 US Other 510(k) Applications for this Company
Contact	Denise Dajles Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2022
Decision Date	05/10/2023
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