The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Flowgun Electrocautery Probe Handle.
| Device ID | K935970 |
| 510k Number | K935970 |
| Device Name: | FLOWGUN ELECTROCAUTERY PROBE HANDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | O.R. CONCEPTS, INC. 12250 NICOLLET AVE. SOUTH Burnsville, MN 55337 |
| Contact | John A Trine |
| Correspondent | John A Trine O.R. CONCEPTS, INC. 12250 NICOLLET AVE. SOUTH Burnsville, MN 55337 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-05-16 |