The following data is part of a premarket notification filed by Triad Surgical Technologies, Inc. with the FDA for Standard & Extended Blade, Standard & Extended Needle, Standard & Extended Ball, Modified Standard & Extended Blade, Mod.
| Device ID | K000333 |
| 510k Number | K000333 |
| Device Name: | STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD |
| Classification | Electrode, Electrosurgical |
| Applicant | TRIAD SURGICAL TECHNOLOGIES, INC. 7786 PROSPECTOR DR. Salt Lake City, UT 84121 |
| Contact | Brian Mcgavin |
| Correspondent | Brian Mcgavin TRIAD SURGICAL TECHNOLOGIES, INC. 7786 PROSPECTOR DR. Salt Lake City, UT 84121 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-05-03 |