The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron 900 High Frequency Dessiccator/handpiece.
| Device ID | K000961 |
| 510k Number | K000961 |
| Device Name: | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009295 | K000961 | 000 |
| 00192896009288 | K000961 | 000 |
| 00192896009226 | K000961 | 000 |
| 00192896009219 | K000961 | 000 |