FDA 510(k) Application Details - K120051

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K120051
Device Name	Nebulizer (Direct Patient Interface)
Applicant	NEPHRON PHARMACEUTICALS CORP. 4121 34TH ST. S.W. ORLANDO, FL 32811-6475 US Other 510(k) Applications for this Company
Contact	MARCUS JULIANO Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2012
Decision Date	04/20/2012
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