The following data is part of a premarket notification filed by Physician Industries, Inc. with the FDA for Physician Industries Radiofrequency Ablation Needle.
| Device ID | K040565 |
| 510k Number | K040565 |
| Device Name: | PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | PHYSICIAN INDUSTRIES, INC. 3395 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Brian Baker |
| Correspondent | Brian Baker PHYSICIAN INDUSTRIES, INC. 3395 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-03 |
| Decision Date | 2004-07-22 |
| Summary: | summary |