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 |