FDA 510(k) Application Details - K180152

Device Classification Name	More FDA Info for this Device
510(K) Number	K180152
Device Name	gel-e Flex
Applicant	gel-e, Inc. 387 Technology Dr., Suite 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	01/19/2018
Decision Date	06/22/2018
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