The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Defrere Electrode.
| Device ID | K851040 |
| 510k Number | K851040 |
| Device Name: | CONCEPT DEFRERE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Penny C Rasmussen |
| Correspondent | Penny C Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-07-11 |