The following data is part of a premarket notification filed by Karlen Mfg., Inc. with the FDA for Opti Pads.
| Device ID | K950940 |
| 510k Number | K950940 |
| Device Name: | OPTI PADS |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | KARLEN MFG., INC. 5401 SOUTH GRAHAM RD. St. Charles, MI 48655 |
| Contact | Lendell J Williams |
| Correspondent | Lendell J Williams KARLEN MFG., INC. 5401 SOUTH GRAHAM RD. St. Charles, MI 48655 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-06-26 |