FDA 510(k) Application Details - K030239

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K030239
Device Name	Mask, Surgical
Applicant	MEGATECH SCIENTIFIC PTE LTD BLK 2 BUKIT BATOK STREET 24 SKYTECH #09-03 659480 SG Other 510(k) Applications for this Company
Contact	CHIAM KIA CHEE 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	01/23/2003
Decision Date	07/24/2003
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