MOLTENO3

Implant, Eye Valve

IOP, INC.

The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Molteno3.

Pre-market Notification Details

Device IDK062252
510k NumberK062252
Device Name:MOLTENO3
ClassificationImplant, Eye Valve
Applicant IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa,  CA  92626
ContactJason Malecka
CorrespondentJason Malecka
IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa,  CA  92626
Product CodeKYF  
CFR Regulation Number886.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-03
Decision Date2006-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09419196000106 K062252 000
09419196000090 K062252 000

Trademark Results [MOLTENO3]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MOLTENO3
MOLTENO3
78682325 3277087 Dead/Cancelled
Molteno, Anthony Christopher Bernard
2005-07-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.