The following data is part of a premarket notification filed by Concept, Inc. with the FDA for All Purpose Electrosurgical Generator.
| Device ID | K841483 |
| 510k Number | K841483 |
| Device Name: | ALL PURPOSE ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Carl A Angles |
| Correspondent | Carl A Angles 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 | 1984-04-10 |
| Decision Date | 1984-10-23 |