FDA 510(k) Application Details - K003338

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K003338
Device Name	Implant, Eye Sphere
Applicant	INTEGRATED ORBITAL IMPLANTS, INC. 4329 GRAYDON RD. SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	FLOYD G LARSON Other 510(k) Applications for this Contact
Regulation Number	886.3320   More FDA Info for this Regulation Number
Classification Product Code	HPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2000
Decision Date	02/07/2001
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