FDA 510(k) Application Details - K122252

Device Classification Name	Holding Chambers, Direct Patient Interface   More FDA Info for this Device
510(K) Number	K122252
Device Name	Holding Chambers, Direct Patient Interface
Applicant	MEDICAL DEVELOPMENTS INTERNATIONAL SUITE 408, 460 PACIFIC HIGHWAY ST LEONARDS 2065 AU Other 510(k) Applications for this Company
Contact	TRACEY BULLIVANT Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	NVP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2012
Decision Date	11/13/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review