The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for 5,6,7,9,10,11,12mm Blunt-tip Trocar Obtur/thread.
| Device ID | K934510 |
| 510k Number | K934510 |
| Device Name: | 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD |
| Classification | Esophagoscope, General & Plastic Surgery |
| Applicant | PHX TECHNOLOGIES CORP. POST OFFICE BOX 1059 Lewisville, TX 75067 |
| Contact | James F Chapel |
| Correspondent | James F Chapel PHX TECHNOLOGIES CORP. POST OFFICE BOX 1059 Lewisville, TX 75067 |
| Product Code | GCL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1994-02-17 |