FDA 510(k) Application Details - K952326

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K952326
Device Name	Nebulizer (Direct Patient Interface)
Applicant	GLOBAL MEDICAL ENT., INC. 1590 WEST 35TH PL. HIALEAH, FL 33012 US Other 510(k) Applications for this Company
Contact	SALVADOR CASTANER 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	05/18/1995
Decision Date	02/27/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review