SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
OPTIKEM INTERNATIONAL, INC.
OPTIK
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004145084 | 3004145084 | OPTIK K & R INC. | 1 | N | 2026-01-01 | 425 Midwest Road Toronto Ontario CA M1P3A6 |
| 1720129 | 1720129 | OPTIKEM INTERNATIONAL, INC. | 1 | N | 2020-04-25 | 2172 SOUTH JASON ST. Denver CO US 80223 |
| 3006738345 | 3006738345 | OPTIKHAN ARTISAN & CO. | 1 | N | 2020-04-25 | 186 CHIMSANRO BUKGU DAEGU Daegu Gwangyeogsi KR 702-858 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 80398 | 1418272511 | P870051 | |||
| 80398 | 1309318632 | P870050 | |||
| 164446 | 1823992452 | K943753 | FRAME SPECTACLE | HQZ | 1994-09-02 |
| 80398 | 2002683786 | K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES | LPN | 2007-06-13 |
| 80398 | 1226366919 | K011561 | SEREINE EXTRA STRENGTH DAILY CLEANER | LPN | 2001-11-20 |
| 67967 | 1721240799 | ||||
| 67967 | 2069692765 |
Product Codes Associated With Registrations#
PMN#
OPTIK LAPAROSCOPE
OPTIK
OPTIKOS SHAMI, INC. SUNGLASSES
OPTIKOS SHAMI, INC.
OPTIKOS SHAMI, INC. SPECTACLE FRAMES
OPTIKOS SHAMI, INC.
COAST VIDEO ENDOSCOPIC IMAGING SYSTEM
OPTIK
PERIKON PCL 90
OPTIKON OFTALMOLOGIA SPA
TITAMED ANTWERP SYSTEM
OPTIK
OPTIKEM PMMA CONTACT LENS
OPTIKEM POLYMERS, INC.
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
OPTIK
LIGHTSCOPE SET
OPTIK
MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
OPTIK
LE CASE HARD CONTACT LENS STORAGE CASE
OPTIKEM INTERNATIONAL, INC.