The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Acu-clens Cleaning System For Contact Lens Cleaning.
| Device ID | K964222 |
| 510k Number | K964222 |
| Device Name: | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-12-20 |
| Summary: | summary |