The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Molteno3.
Device ID | K062252 |
510k Number | K062252 |
Device Name: | MOLTENO3 |
Classification | Implant, Eye Valve |
Applicant | IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
Contact | Jason Malecka |
Correspondent | Jason Malecka IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
Product Code | KYF |
CFR Regulation Number | 886.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-03 |
Decision Date | 2006-09-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09419196000106 | K062252 | 000 |
09419196000090 | K062252 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MOLTENO3 78682325 3277087 Dead/Cancelled |
Molteno, Anthony Christopher Bernard 2005-07-31 |