The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Non-sterile Holster, Sterile Holster Model Esh1-ns, Esh1, Es Pencil W/ Holster, Es Smoke & Fluid Pencil W/ Holster Model.
| Device ID | K981614 |
| 510k Number | K981614 |
| Device Name: | NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL |
| 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 | 1998-05-06 |
| Decision Date | 1998-07-17 |