The following data is part of a premarket notification filed by A. Stein - Regulatory Affairs Consulting with the FDA for Easy-jet Device.
| Device ID | K972383 |
| 510k Number | K972383 |
| Device Name: | EASY-JET DEVICE |
| Classification | Tube, Shunt, Endolymphatic With Valve |
| Applicant | A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853 |
| Product Code | KLZ |
| CFR Regulation Number | 874.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1999-11-23 |