FDA 510(k) Application Details - K182811

Device Classification Name	More FDA Info for this Device
510(K) Number	K182811
Device Name	gel-e Flex+
Applicant	gel-e, Inc. 387 Technology Dr., Ste 3110B College Park, MD 20742 US Other 510(k) Applications for this Company
Contact	Elsa Abruzzo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2018
Decision Date	08/29/2019
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