The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Standard And Extended Blade, Needle And Ball; Modified Standard And Extended Blade & Needle; Standard 45 Degree Blade.
| Device ID | K974735 |
| 510k Number | K974735 |
| Device Name: | STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE |
| Classification | Electrode, Electrosurgical |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | J. Robert Saron |
| Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-18 |
| Decision Date | 1998-06-24 |