The following data is part of a premarket notification filed by Optics Laboratory, Inc. with the FDA for Eye-cept Rewetting Drops.
| Device ID | K041008 |
| 510k Number | K041008 |
| Device Name: | EYE-CEPT REWETTING DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | OPTICS LABORATORY, INC. 5408 INTERSTATE DRIVE Shreveport, LA 71109 |
| Contact | J.r. Chen |
| Correspondent | J.r. Chen OPTICS LABORATORY, INC. 5408 INTERSTATE DRIVE Shreveport, LA 71109 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2005-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00364108411121 | K041008 | 000 |