The following data is part of a premarket notification filed by Aaron Medical, Inc. with the FDA for Surgical Electrical Pencil.
| Device ID | K913623 |
| 510k Number | K913623 |
| Device Name: | SURGICAL ELECTRICAL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL, INC. 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
| Contact | Robert Saron |
| Correspondent | Robert Saron AARON MEDICAL, INC. 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1992-02-21 |