FDA 510(k) Application Details - K172010

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K172010
Device Name	Dressing, Wound, Drug
Applicant	gel-e, Inc. (formerly Remedium Technologies, Inc.) 387 Technology Dr., Ste 3110B College Park, MD 20742 US Other 510(k) Applications for this Company
Contact	Matthew Dowling Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2017
Decision Date	12/07/2017
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