The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron Coolpad Split W/o Cord,aaron Coolpad Split With Cord, Aaron Coolpad W/o Cord, Arron Coolpad With Cord, Models Esre.
| Device ID | K983788 |
| 510k Number | K983788 |
| Device Name: | AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-27 |
| Decision Date | 1998-11-25 |