The following data is part of a premarket notification filed by Tedan Surgical Innovations, Llc with the FDA for Phantom Xl Insulated Dilators.
| Device ID | K140088 |
| 510k Number | K140088 |
| Device Name: | PHANTOM XL INSULATED DILATORS |
| Classification | Neurosurgical Nerve Locator |
| Applicant | TEDAN SURGICAL INNOVATIONS, LLC 12615 W AIRPORT BLVD, SUITE 200 Sugar Land, TX 77478 |
| Contact | Joann(dionicia) Reblando |
| Correspondent | Joann(dionicia) Reblando TEDAN SURGICAL INNOVATIONS, LLC 12615 W AIRPORT BLVD, SUITE 200 Sugar Land, TX 77478 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-14 |
| Decision Date | 2014-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851797006436 | K140088 | 000 |
| 00851797006191 | K140088 | 000 |
| 00851797006146 | K140088 | 000 |
| 00851797006139 | K140088 | 000 |
| 00851797006122 | K140088 | 000 |