The following data is part of a premarket notification filed by Optics Laboratory, Inc with the FDA for Eye-cept Sterile Saline Solution.
| Device ID | K110221 |
| 510k Number | K110221 |
| Device Name: | EYE-CEPT STERILE SALINE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | OPTICS LABORATORY, INC 9480 TELSTAR AVE SUITE 3 El Monte, CA 91731 -2988 |
| Contact | Patricia Chiu |
| Correspondent | Patricia Chiu OPTICS LABORATORY, INC 9480 TELSTAR AVE SUITE 3 El Monte, CA 91731 -2988 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2011-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00364108431242 | K110221 | 000 |