FDA 510(k) Application Details - K984389

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K984389
Device Name	Mask, Surgical
Applicant	TOP WHOLESOME ENTERPRISE CO., LTD. A.P. NAKARINTR TOWER 18TH FL 333 MOO 9, SRINAKARINTR RD. BANGNA 10260 TH Other 510(k) Applications for this Company
Contact	URAI CHAROENSUK Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/1998
Decision Date	04/09/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review