The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Boat Nose Obturator.
| Device ID | K954458 |
| 510k Number | K954458 |
| Device Name: | BOAT NOSE OBTURATOR |
| Classification | Arthroscope |
| Applicant | PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Contact | James D Chapel |
| Correspondent | James D Chapel PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1995-10-23 |