The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for A & Em Medical Electrosurgical Pencil/accessories.
| Device ID | K915300 |
| 510k Number | K915300 |
| Device Name: | A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
| Contact | Tim Wojciechowicz |
| Correspondent | Tim Wojciechowicz ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-21 |
| Decision Date | 1992-02-18 |