Device Classification Name implant, eye valve
510(k) Number K890598
Device Name MOLTENO IMPLANT
Applicant
IOP, INC.
22653 PACIFIC COAST HWY
SUITE 340
malibu,  CA  90265
Applicant Contact jason malecka
Correspondent
IOP, INC.
22653 PACIFIC COAST HWY
SUITE 340
malibu,  CA  90265
Correspondent Contact jason malecka
Regulation Number886.3920
Classification Product Code
KYF  
Date Received02/06/1989
Decision Date 02/27/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No