The following data is part of a premarket notification filed by U-molde Systems, Inc. with the FDA for Plastic Optical Lens M-110.
| Device ID | K834261 |
| 510k Number | K834261 |
| Device Name: | PLASTIC OPTICAL LENS M-110 |
| Classification | Unit, Phacofragmentation |
| Applicant | U-MOLDE SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-03-16 |