The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron Top50 Reusable Electrosurgical Pencil, Model #espr.
| Device ID | K984352 |
| 510k Number | K984352 |
| Device Name: | AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR |
| 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 | 1998-12-04 |
| Decision Date | 1999-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009431 | K984352 | 000 |