The following data is part of a premarket notification filed by Geotek Medikal Ltd Sti with the FDA for Gtk Disposable Needle Guides.
| Device ID | K170741 |
| 510k Number | K170741 |
| Device Name: | GTK Disposable Needle Guides |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GEOTEK Medikal Ltd Sti Ivedik OSB, Agac Metal Sitesi 1436 Sk. No:12 Ankara, TR 06738 |
| Contact | Latif Iba |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-06-01 |