The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Stone Extractor.
| Device ID | K971123 |
| 510k Number | K971123 |
| Device Name: | STONE EXTRACTOR |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Contact | James F Chapel |
| Correspondent | James F Chapel PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-06-27 |
| Summary: | summary |