The following data is part of a premarket notification filed by New Deantronics, Ltd. with the FDA for Return Electrode Clamp Shell Cord Model Rc 201.
| Device ID | K982130 |
| 510k Number | K982130 |
| Device Name: | RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 |
| 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 | 1998-06-17 |
| Decision Date | 1998-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813527027443 | K982130 | 000 |
| 20813527027436 | K982130 | 000 |
| 20813527027429 | K982130 | 000 |
| 10614559103890 | K982130 | 000 |