The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Hp Pro Positioning Device.
| Device ID | K171734 |
| 510k Number | K171734 |
| Device Name: | HP PRO Positioning Device |
| Classification | Accelerator, Linear, Medical |
| Applicant | Orfit Industries NV 9A, Vosveld Wijnegem, BE 2110 |
| Contact | Eddy Marivoet |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-07-25 |
| Summary: | summary |