The following data is part of a premarket notification filed by Optopics Laboratories Corp. with the FDA for Wetting Solution For Hard Contact Lenses.
| Device ID | K914483 |
| 510k Number | K914483 |
| Device Name: | WETTING SOLUTION FOR HARD CONTACT LENSES |
| Classification | Accessories, Soft Lens Products |
| Applicant | OPTOPICS LABORATORIES CORP. P.O. BOX 210 Fairton, NJ 08320 -0210 |
| Contact | Scott H Nicholas |
| Correspondent | Scott H Nicholas OPTOPICS LABORATORIES CORP. P.O. BOX 210 Fairton, NJ 08320 -0210 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1992-02-05 |