K972383 is an FDA 510(k) clearance for the EASY-JET DEVICE. This device is classified as a Tube, Shunt, Endolymphatic With Valve (Class II - Special Controls, product code KLZ).
Submitted by A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on November 23, 1999, 880 days after receiving the submission on June 26, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3850.
| 510(k) Number | K972383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1997 |
| Decision Date | November 23, 1999 |
| Days to Decision | 880 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | KLZ — Tube, Shunt, Endolymphatic With Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3850 |