The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for A&e Medical Electrosurg Electro W/non-stick Coat.
| Device ID | K931537 |
| 510k Number | K931537 |
| Device Name: | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT |
| 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 | 1993-03-29 |
| Decision Date | 1993-09-07 |