FDA 510(k) Application Details - K050988

Device Classification Name	Coating, Liquid, Glc   More FDA Info for this Device
510(K) Number	K050988
Device Name	Coating, Liquid, Glc
Applicant	Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. SUNNYVALE, CA 94085-2917 US Other 510(k) Applications for this Company
Contact	MARIE LIN Other 510(k) Applications for this Contact
Regulation Number	862.2250   More FDA Info for this Regulation Number
Classification Product Code	DLG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2005
Decision Date	04/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review