The following data is part of a premarket notification filed by Plasma Surgical, Ltd. with the FDA for Plasmajet Neutral Plasma Surgery System.
| Device ID | K080197 |
| 510k Number | K080197 |
| Device Name: | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PLASMA SURGICAL, LTD. BRUNEL ROAD Theale, Berkshire, GB Rg7 4aq |
| Contact | Peter Gibson |
| Correspondent | Peter Gibson PLASMA SURGICAL, LTD. BRUNEL ROAD Theale, Berkshire, GB Rg7 4aq |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-06-24 |