K960584 is an FDA 510(k) clearance for the NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Novavision, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 15, 1996, 185 days after receiving the submission on February 12, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K960584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1996 |
| Decision Date | August 15, 1996 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |