The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for High Temperature Cautery.
| Device ID | K945765 |
| 510k Number | K945765 |
| Device Name: | HIGH TEMPERATURE CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Contact | J R Saron |
| Correspondent | J R Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304406612 | K945765 | 000 |
| 00880304377448 | K945765 | 000 |