The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Electrodes (blade, Ball, Needle, And Loop).
| Device ID | K942986 |
| 510k Number | K942986 |
| Device Name: | ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Contact | J. Robert Saron |
| Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1995-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009417 | K942986 | 000 |
| 00821925010543 | K942986 | 000 |