FDA 510(k) Application Details - K112634

Device Classification Name	Chamber, Oxygen, Topical, Extremity   More FDA Info for this Device
510(K) Number	K112634
Device Name	Chamber, Oxygen, Topical, Extremity
Applicant	INOTEC AMD LTD. 2995 STEVEN MARTIN DR. FAIRFAX, VA 22031 US Other 510(k) Applications for this Company
Contact	Diane Horwitz 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	09/09/2011
Decision Date	07/03/2012
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