SAGITTILT
Accelerator, Linear, Medical
ORFIT INDUSTRIES NV
The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Sagittilt.
Pre-market Notification Details
| Device ID | K141787 |
| 510k Number | K141787 |
| Device Name: | SAGITTILT |
| Classification | Accelerator, Linear, Medical |
| Applicant | ORFIT INDUSTRIES NV 10882 STONINGTON AVE. Fort Myers, FL 33913 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter ORFIT INDUSTRIES NV 10882 STONINGTON AVE. Fort Myers, FL 33913 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-08-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420028777268 | K141787 | 000 |
| 05420028773499 | K141787 | 000 |
| 05420028702529 | K141787 | 000 |
| 05420028700396 | K141787 | 000 |
Trademark Results [SAGITTILT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAGITTILT 79150893 4690456 Live/Registered |
ORFIT INDUSTRIES, naamloze vennootschap 2014-05-09 |
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