FDA 510(k) Application Details - K082878

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K082878
Device Name	Nebulizer (Direct Patient Interface)
Applicant	NSR COMERCIO E REPRESENTACOES LTDA 11 PERRY DRIVE UNIT G FOXBORO, MA 02035 US Other 510(k) Applications for this Company
Contact	POLLY SCHERMAN 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	09/29/2008
Decision Date	12/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review