The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Variable Temperature Cautery Device.
| Device ID | K843974 |
| 510k Number | K843974 |
| Device Name: | VARIABLE TEMPERATURE CAUTERY DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NATIONAL PATENT DEVELOPMENT CORP. 783 JERSEY AVE. New Brunswick, NJ 08901 |
| Contact | Albert A Ghignone |
| Correspondent | Albert A Ghignone NATIONAL PATENT DEVELOPMENT CORP. 783 JERSEY AVE. New Brunswick, NJ 08901 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1985-02-26 |