The following data is part of a premarket notification filed by Castle Co. with the FDA for Bovie Conductive Adhes-disper-electro.
| Device ID | K834048 |
| 510k Number | K834048 |
| Device Name: | BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CASTLE CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-04-04 |