The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Sterile, Disposable Endo Speciemen Retrieval Bag.
| Device ID | K934165 |
| 510k Number | K934165 |
| Device Name: | STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG |
| 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 | 1994-01-25 |