FDA 510(k) Application Details - K001326

Device Classification Name	Button, Iris, Eye, Artificial   More FDA Info for this Device
510(K) Number	K001326
Device Name	Button, Iris, Eye, Artificial
Applicant	OCULAR CONCEPTS LLC. 4035 SW MERCANTILE DR. SUITE 208 PORTLAND, OR 97035-2591 US Other 510(k) Applications for this Company
Contact	KEVIN SCHOU Other 510(k) Applications for this Contact
Regulation Number	886.3200   More FDA Info for this Regulation Number
Classification Product Code	NCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2000
Decision Date	06/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review