The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Winged Needle Holder.
| Device ID | K974327 |
| 510k Number | K974327 |
| Device Name: | WINGED NEEDLE HOLDER |
| Classification | Holder, Needle, Gastroenterologic |
| Applicant | PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Contact | James F Chapel, Ph.d. |
| Correspondent | James F Chapel, Ph.d. PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205 |
| Product Code | FHQ |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1998-01-09 |
| Summary: | summary |