The following data is part of a premarket notification filed by Ciba Vision Care with the FDA for Professional Disinfection System (pds).
| Device ID | K863346 |
| 510k Number | K863346 |
| Device Name: | PROFESSIONAL DISINFECTION SYSTEM (PDS) |
| Classification | Accessories, Soft Lens Products |
| Applicant | CIBA VISION CARE P.O. BOX 105069 Atlanta, GA 30348 |
| Contact | Paul G Stapleton |
| Correspondent | Paul G Stapleton CIBA VISION CARE P.O. BOX 105069 Atlanta, GA 30348 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-29 |
| Decision Date | 1987-02-27 |