ESTEYA
System, Therapeutic, X-ray
NUCLETRON B.V.
The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Esteya.
Pre-market Notification Details
| Device ID | K132092 |
| 510k Number | K132092 |
| Device Name: | ESTEYA |
| Classification | System, Therapeutic, X-ray |
| Applicant | NUCLETRON B.V. 1917 29 3/4 AVE. Rice Lake, WI 54868 |
| Contact | Lu Anne Johnson |
| Correspondent | Lu Anne Johnson NUCLETRON B.V. 1917 29 3/4 AVE. Rice Lake, WI 54868 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
Trademark Results [ESTEYA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTEYA 79116060 4366437 Live/Registered |
Nucletron Operations B.V. 2012-05-21 |
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