FDA 510(k) Application Details - K190742

Device Classification Name	Chamber, Oxygen, Topical, Extremity   More FDA Info for this Device
510(K) Number	K190742
Device Name	Chamber, Oxygen, Topical, Extremity
Applicant	Neogenix, LLC dba Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122 US Other 510(k) Applications for this Company
Contact	Srinivasan Sarangapani Other 510(k) Applications for this Contact
Regulation Number	878.5650   More FDA Info for this Regulation Number
Classification Product Code	KPJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2019
Decision Date	12/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review