The following data is part of a premarket notification filed by Optikem International, Inc. with the FDA for Sereine Extra Strength Daily Cleaner For Silicone Hydrogel (sihy) Soft Contact Lenses.
| Device ID | K071203 |
| 510k Number | K071203 |
| Device Name: | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES |
| Classification | Accessories, Soft Lens Products |
| Applicant | OPTIKEM INTERNATIONAL, INC. 2214 SANFORD DRIVE UNIT B7 Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing OPTIKEM INTERNATIONAL, INC. 2214 SANFORD DRIVE UNIT B7 Grand Junction, CO 81505 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-01 |
| Decision Date | 2007-06-13 |
| Summary: | summary |