The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Bipolar Coagulator #9620/9621.
Device ID | K823184 |
510k Number | K823184 |
Device Name: | BIPOLAR COAGULATOR #9620/9621 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-26 |
Decision Date | 1982-12-03 |