The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-zyme(r).
| Device ID | K873548 |
| 510k Number | K873548 |
| Device Name: | OPTI-ZYME(R) |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
| Contact | Rebecca G Walker |
| Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-09-29 |