FDA 510(k) Application Details - K002279

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K002279
Device Name	Sponge, Ophthalmic
Applicant	MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK 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	07/26/2000
Decision Date	08/18/2000
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