The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Electrosurgical Tip Cleaner, Tip Cleaning Pad, Lectrobrasive Tip Cleaner, Electrosurgical Tip Cleaner, Electrode Tip Cle.
| Device ID | K971805 |
| 510k Number | K971805 |
| Device Name: | ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-15 |
| Decision Date | 1997-06-13 |