The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical Generator, 240v.
| Device ID | K021817 |
| 510k Number | K021817 |
| Device Name: | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A 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 | 2002-06-03 |
| Decision Date | 2002-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009202 | K021817 | 000 |
| 00192896009196 | K021817 | 000 |
| 00192896009189 | K021817 | 000 |
| 20612479212927 | K021817 | 000 |