FDA 510(k) Application Details - K101348

Device Classification Name	Holding Chambers, Direct Patient Interface   More FDA Info for this Device
510(K) Number	K101348
Device Name	Holding Chambers, Direct Patient Interface
Applicant	AGAPLASTIC IND. COM. LTDA. 55 Northern Blvd Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	MARIA F GRIFFIN 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	05/13/2010
Decision Date	04/29/2011
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