The following data is part of a premarket notification filed by Plasma Surgical, Ltd. with the FDA for Plasmajet System.
| Device ID | K030819 |
| 510k Number | K030819 |
| Device Name: | PLASMAJET SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PLASMA SURGICAL, LTD. 18, GROSVENOR STREET London, GB W1k 4qq |
| Contact | Peter F Gibson |
| Correspondent | Peter F Gibson PLASMA SURGICAL, LTD. 18, GROSVENOR STREET London, GB W1k 4qq |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2004-08-05 |
| Summary: | summary |