FDA 510(k) Application Details - K082460

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K082460
Device Name	Sponge, Ophthalmic
Applicant	LONGTEK SCIENTIFIC CO., LTD. 7128 STAFFORDSHIRE ST. HOUSTON, TX 77030 US Other 510(k) Applications for this Company
Contact	JOSEPH J CHANG Other 510(k) Applications for this Contact
Regulation Number	886.4790   More FDA Info for this Regulation Number
Classification Product Code	HOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2008
Decision Date	12/15/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review