FDA 510(k) Application Details - K003646

Device Classification Name	Weights, Eyelid, External   More FDA Info for this Device
510(K) Number	K003646
Device Name	Weights, Eyelid, External
Applicant	IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	JASON MALECKA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2000
Decision Date	02/22/2001
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review