The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Hydro-probe.
Device ID | K934157 |
510k Number | K934157 |
Device Name: | HYDRO-PROBE |
Classification | Laparoscope, 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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-24 |
Decision Date | 1994-01-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDRO-PROBE 74447451 1902447 Live/Registered |
Hydronix Limited 1993-10-15 |