The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron 2100 High Frequency Electrosurgical Generator.
| Device ID | K001382 |
| 510k Number | K001382 |
| Device Name: | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Rick Kozloff |
| Correspondent | Rick Kozloff AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-06-27 |