The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Phx Technologies Corp., Grasper-retractor Device.
Device ID | K933895 |
510k Number | K933895 |
Device Name: | PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE |
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 | 1993-08-10 |
Decision Date | 1993-12-29 |