The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Low Temperature Cautery Elongated Fine Tip.
| Device ID | K945763 |
| 510k Number | K945763 |
| Device Name: | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| 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 | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-02-07 |