The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for Disposable Hand Switching Pencil, Rocker Switch, One Piece And One Piece Holster Models Sb 313 Rs, Sb 313 Rsh.
| Device ID | K982742 |
| 510k Number | K982742 |
| Device Name: | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEW DEANTRONICS TAIWAN, LTD. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward NEW DEANTRONICS TAIWAN, 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 | 1998-08-06 |
| Decision Date | 1998-09-14 |