FDA 510(k) Application Details - K050716

Device Classification Name	Pump, Infusion, Ophthalmic   More FDA Info for this Device
510(K) Number	K050716
Device Name	Pump, Infusion, Ophthalmic
Applicant	ISCIENCE SURGICAL CORPORATION 2 DELPHINUS IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	JUDY F GORDON Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2005
Decision Date	04/21/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review