The following data is part of a premarket notification filed by Novavision, Inc. with the FDA for Novalens/novawet Sphjerical & Perception & Vanguard Multifocal &/or Bifocal (rosifocon A) Rigid Gas Permeable Contact Lr.
| Device ID | K955900 |
| 510k Number | K955900 |
| Device Name: | NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | NOVAVISION, INC. 2700-200 GATEWAY CENTRE BLVD. Morrisville, NC 27560 |
| Contact | Alan J Touch |
| Correspondent | Alan J Touch NOVAVISION, INC. 2700-200 GATEWAY CENTRE BLVD. Morrisville, NC 27560 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-29 |
| Decision Date | 1996-03-25 |