The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for A&e Medical Corp Dispos Suct Coag W/non Stick Coat.
| Device ID | K914193 |
| 510k Number | K914193 |
| Device Name: | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
| Contact | F Wojciechowicz |
| Correspondent | F 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 | 1991-09-18 |
| Decision Date | 1992-10-05 |