The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for Monopolar Foot Control Pencil, Model # Sb 112-2.
| Device ID | K982749 |
| 510k Number | K982749 |
| Device Name: | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521782577 | K982749 | 000 |
| 20884521782614 | K982749 | 000 |
| 20884521782591 | K982749 | 000 |
| 20884521782584 | K982749 | 000 |
| 20884521782607 | K982749 | 000 |
| 20884521782621 | K982749 | 000 |
| 20884521782645 | K982749 | 000 |