The following data is part of a premarket notification filed by New Deantronics, Ltd. with the FDA for Disposable Hand Switching Pencil, Rocker Switch Two Piece, Sb 312rs, Two Disposable Hand Switching Pencil, Rocker Switch.
| Device ID | K982884 |
| 510k Number | K982884 |
| Device Name: | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEW DEANTRONICS, LTD. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward NEW DEANTRONICS, LTD. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-09-14 |