The following data is part of a premarket notification filed by Novavision, Inc. with the FDA for Novanew Reconditioning System For Prof. Use In-office Use Only.
| Device ID | K960584 |
| 510k Number | K960584 |
| Device Name: | NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY |
| 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 | 1996-02-12 |
| Decision Date | 1996-08-15 |