The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240.
| Device ID | K980366 |
| 510k Number | K980366 |
| Device Name: | AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Rob Saron |
| Correspondent | Rob Saron 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 | 1998-01-29 |
| Decision Date | 1998-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151112035 | K980366 | 000 |
| 00607151001506 | K980366 | 000 |