The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System.
| Device ID | K021804 |
| 510k Number | K021804 |
| Device Name: | PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVE NE Minneapolis, MN 55421 |
| Contact | Julie Goode |
| Correspondent | Julie Goode MEDTRONIC VASCULAR 800 53RD AVE NE Minneapolis, MN 55421 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2002-08-28 |
| Summary: | summary |