FDA 510(k) Application Details - K990435

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K990435
Device Name	Nebulizer (Direct Patient Interface)
Applicant	APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET HSI-CHIH CITY, TAIPEI HSIEN TW Other 510(k) Applications for this Company
Contact	DANIEL LEE 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	02/11/1999
Decision Date	06/05/2000
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