FDA 510(k) Application Details - K091240

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K091240
Device Name	Sponge, Ophthalmic
Applicant	ALPHAMED INC. 3912 MOUNTAIN AVE. EL PASO, TX 79930 US Other 510(k) Applications for this Company
Contact	JAMES GUBACHY 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	04/27/2009
Decision Date	10/23/2009
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