FDA 510(k) Application Details - K972661

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K972661
Device Name	Implant, Eye Sphere
Applicant	GULDEN OPHTHALMICS 225 CADWALADER AVE. ELKINS PARK, PA 19027-2020 US Other 510(k) Applications for this Company
Contact	THOMAS COCKLEY 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	07/16/1997
Decision Date	10/03/1997
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