The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Flowgun Electrocautery Probes.
Device ID | K935971 |
510k Number | K935971 |
Device Name: | FLOWGUN ELECTROCAUTERY PROBES |
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 |